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16 "Vinorelbine"
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Combination Therapy of Pyrotinib and Metronomic Vinorelbine in HER2+ Advanced Breast Cancer after Trastuzumab Failure (PROVE): A Prospective Phase 2 Study
Chunfang Hao, Xu Wang, Yehui Shi, Zhongsheng Tong, Shufen Li, Xiaodong Liu, Lan Zhang, Jie Zhang, Wenjing Meng, Li Zhang
Received April 3, 2024  Accepted August 8, 2024  Published online August 9, 2024  
DOI: https://doi.org/10.4143/crt.2024.340    [Epub ahead of print]
AbstractAbstract PDFPubReaderePub
Purpose
Approximately 50%-74% of patients with metastatic human epidermal growth factor receptor 2 (HER2)–positive breast cancer do not respond to trastuzumab, with 75% of treated patients experiencing disease progression within a year. The combination of pyrotinib and capecitabine has showed efficacy in these patients. This study evaluates the efficacy and safety of pyrotinib combined with metronomic vinorelbine for trastuzumab-pretreated HER2-positive advanced breast cancer patients.
Materials and Methods
In this phase 2 trial, patients aged 18-75 years with HER2-positive advanced breast cancer who had previously failed trastuzumab treatment were enrolled to receive pyrotinib 400 mg daily in combination with vinorelbine 40mg thrice weekly. The primary endpoint was progression-free survival (PFS), while secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety.
Results
From October 21, 2019, to January 21, 2022, 36 patients were enrolled and received at least one dose of study treatment. At the cutoff date, 20 experienced disease progression or death. With a median follow-up duration of 35 months, the median PFS was 13.5 months (95% confidence interval [CI], 8.3 to 18.5). With all patients evaluated, an ORR of 38.9% (95% CI, 23.1 to 56.5) and a DCR of 83.3% (95% CI, 67.2 to 93.6) were achieved. The median OS was not reached. Grade 3 adverse events (AEs) were observed in 17 patients, with diarrhea being the most common (27.8%), followed by vomiting (8.3%) and stomachache (5.6%). There were no grade 4/5 AEs.
Conclusion
Pyrotinib combined with metronomic vinorelbine showed promising efficacy and an acceptable safety profile in HER2-positive advanced breast cancer patients after trastuzumab failure.
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Breast cancer
Pyrotinib Combined with Vinorelbine in Patients with Previously Treated HER2-Positive Metastatic Breast Cancer: A Multicenter, Single-Arm, Prospective Study
Kuikui Jiang, Ruoxi Hong, Wen Xia, Qianyi Lu, Liang Li, Jianhao Huang, Yanxia Shi, Zhongyu Yuan, Qiufan Zheng, Xin An, Cong Xue, Jiajia Huang, Xiwen Bi, Meiting Chen, Jingmin Zhang, Fei Xu, Shusen Wang
Cancer Res Treat. 2024;56(2):513-521.   Published online October 12, 2023
DOI: https://doi.org/10.4143/crt.2023.786
AbstractAbstract PDFPubReaderePub
Purpose
This study aims to evaluate the efficacy and safety of a new combination treatment of vinorelbine and pyrotinib in human epidermal growth factor receptor 2 (HER2)–positive metastatic breast cancer (MBC) and provide higher level evidence for clinical practice.
Materials and Methods
This was a prospective, single-arm, phase 2 trial conducted at three institutions in China. Patients with HER2-positive MBC, who had previously been treated with trastuzumab plus a taxane or trastuzumab plus pertuzumab combined with a chemotherapeutic agent, were enrolled between March 2020 and December 2021. All patients received pyrotinib 400 mg orally once daily plus vinorelbine 25 mg/m2 intravenously or 60-80 mg/m2 orally on day 1 and day 8 of 21-day cycle. The primary endpoint was progression-free survival (PFS), and the secondary endpoints included the objective response rate (ORR), disease control rate (DCR), overall survival, and safety.
Results
A total of 39 patients were enrolled. All patients had been pretreated with trastuzumab and 23.1% (n=9) of them had accepted trastuzumab plus pertuzumab. The median follow-up time was 16.3 months (95% confidence interval [CI], 5.3 to 27.2), and the median PFS was 6.4 months (95% CI, 4.0 to 8.8). The ORR was 43.6% (95% CI, 27.8% to 60.4%) and the DCR was 84.6% (95% CI, 69.5% to 94.1%). The median PFS of patients with versus without prior pertuzumab treatment was 4.6 and 8.3 months (p=0.017). The most common grade 3/4 adverse events were diarrhea (28.2%), neutrophil count decreased (15.4%), white blood cell count decreased (7.7%), vomiting (5.1%), and anemia (2.6%).
Conclusion
Pyrotinib plus vinorelbine showed promising efficacy and tolerable toxicity as second-line treatment in patients with HER2-positive MBC.

Citations

Citations to this article as recorded by  
  • Unraveling the future: Innovative design strategies and emerging challenges in HER2-targeted tyrosine kinase inhibitors for cancer therapy
    Sixiang Zheng, Ruixian Chen, Lele Zhang, Lun Tan, Lintao Li, Fangyi Long, Ting Wang
    European Journal of Medicinal Chemistry.2024; 276: 116702.     CrossRef
  • Pyrotinib combined with metronomic etoposide in heavily pretreated HER2-positive metastatic breast cancer: a single-arm, phase II study
    Jiaxuan Liu, Maiyue He, Mingxia Jiang, Shihan Zhou, Mengqi Zhang, Yiqun Li, Shanshan Chen, Ruigang Cai, Hongnan Mo, Bo Lan, Fei Ma, Binghe Xu, Qiao Li
    BMC Cancer.2024;[Epub]     CrossRef
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A Randomized Phase II Trial of Capecitabine Plus Vinorelbine Followed by Docetaxel Versus Adriamycin Plus Cyclophosphamide Followed by Docetaxel as Neoadjuvant Chemotherapy for Breast Cancer
Changhoon Yoo, Sung-Bae Kim, Jin-Hee Ahn, Jeong Eun Kim, Kyung Hae Jung, Gyung-Yub Gong, Byung-Ho Son, Sei-Hyun Ahn, Seung Do Ahn, Hak-Hee Kim, Hee Jung Shin, Woo Kun Kim
Cancer Res Treat. 2015;47(3):406-415.   Published online November 27, 2014
DOI: https://doi.org/10.4143/crt.2014.073
AbstractAbstract PDFPubReaderePub
Purpose
Given the promising activity of capecitabine and vinorelbine in metastatic breast cancer, this randomized phase II trial evaluated the efficacy and safety of this combination as neoadjuvant chemotherapy in breast cancer. Materials and Methods Patients with operable breast cancer (n=75) were randomly assigned to receive either four cycles of adriamycin 60 mg/m2 plus cyclophosphamide 600 mg/m2 every 3 weeks followed by four cycles of docetaxel 75 mg/m2 every 3 weeks (AC-D) or four cycles of capecitabine 2,000 mg/m2 (day 1-14) plus vinorelbine 25 mg/m2 (days 1 and 8) every 3 weeks followed by four cycles of docetaxel 75 mg/m2 (CV-D). The primary endpoint was pathologic complete response (pCR) in the primary breast (ypT0/is). Results Most patients (84%) had locally advanced (n=41) or inflammatory breast cancer (n=22). pCR rates in the primary breast were 15% (95% confidence interval [CI], 7% to 30%) and 11% (95% CI, 4% to 26%) in the AC-D and CV-D groups, respectively. The overall response rates and 5-year progression-free survival rates in the AC-D and CV-D groups were 62% and 64%, and 51.3% (95% CI, 34.6% to 68.0%) and 30.2% (95% CI, 13.3% to 47.1%), respectively. Although both regimens were well tolerated, CV-D showed less frequent grade 3-4 neutropenia and vomiting than AC-D, whereas manageable diarrhea and hand-foot syndrome were more common in the CV-D group. Conclusion CV-D is a feasible and active non-anthracycline–based neoadjuvant chemotherapy regimen for breast cancer.

Citations

Citations to this article as recorded by  
  • Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer
    Siao-Nge Hoon, Peter K H Lau, Alison M White, Max K Bulsara, Patricia D Banks, Andrew D Redfern
    Cochrane Database of Systematic Reviews.2021;[Epub]     CrossRef
  • rApoptin induces apoptosis in human breast cancer cells via phosphorylation of Nur77 and Akt
    Zhenhuan Hou, Jun Mao, Ying Lu, Lianhong Li
    Biochemical and Biophysical Research Communications.2018; 498(1): 221.     CrossRef
  • Neoadjuvant systemic therapy in breast cancer: Challenges and uncertainties
    Mick Van de Wiel, Yanina Dockx, Tim Van den Wyngaert, Sigrid Stroobants, Wiebren A.A. Tjalma, Manon T. Huizing
    European Journal of Obstetrics & Gynecology and Reproductive Biology.2017; 210: 144.     CrossRef
  • Human serum albumin-mediated apoptin delivery suppresses breast cancer cell growth in vitro and in vivo
    Fang Wu, Yizhi Liu, Jian Li, Lei Hou, Fuxi Lei, Shangke Huang, Lu Feng, Xinhan Zhao
    Oncology Letters.2017; 13(2): 579.     CrossRef
  • Capecitabine in Combination with Standard (Neo)Adjuvant Regimens in Early Breast Cancer: Survival Outcome from a Meta-Analysis of Randomized Controlled Trials
    Ze-Chun Zhang, Qi-Ni Xu, Sui-Ling Lin, Xu-Yuan Li, Hemant Kumar Bid
    PLOS ONE.2016; 11(10): e0164663.     CrossRef
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Gemcitabine and Vinorelbine Combination Chemotherapy in Anthracycline- and Taxane-pretreated Advanced Breast Cancer
Hye Jin Kim, Jin-Soo Kim, Myung-Deok Seo, So-Yeon Oh, Do-Youn Oh, Jee Hyun Kim, Se-Hoon Lee, Dong-Wan Kim, Seock-Ah Im, Tae-You Kim, Dae Seog Heo, Yung-Jue Bang
Cancer Res Treat. 2008;40(2):81-86.   Published online June 30, 2008
DOI: https://doi.org/10.4143/crt.2008.40.2.81
AbstractAbstract PDFPubReaderePub
Purpose

Anthracycline and taxanes are effective agents in advanced breast cancer and prolong survival times. Some patients achieve prolongation of life with capecitabine, gemcitabine, or vinorelbine, even after failure of both anthracycline and taxanes. We analyzed the efficacy and toxicity of gemcitabine and vinorelbine combination chemotherapy in anthracycline- and taxane-pretreated advanced breast cancer.

Materials and Methods

The medical records of anthracycline- and taxane-pretreated metastatic breast cancer patients who received gemcitabine and vinorelbine combination chemotherapy at the Seoul National University Hospital were reviewed. Gemcitabine (1,000 mg/m2) and vinorelbine (25 mg/m2) were administered intravenously on days 1 and 8 every 3 weeks.

Results

Between 2000 and 2006, 57 patients were eligible (median age, 45 years), and the median number of previous chemotherapy regimens was 3 (range, 1~5). The overall response rate was 30% (95% CI, 18.1~41.9), and the disease control rate was 46% (PR, 30%; SD, 16%). The median duration of follow-up was 33.4 months, the median time-to-progression (TTP) was 3.9 months, and the median overall survival was 10.8 months. None of thepatients with patients with anthracycline and taxane primary resistance showed a response and the median TTP for these patients was significantly shorter than that of other patients (1.9 vs. 4.4 months; p=0.018). Although the efficacy was unsatisfactory in patients with both anthracycline and taxane primary resistance, gemcitabine and vinorelbine combination chemotherapy showed comparable efficacy in anthracycline- and/or taxane-sensitive patients and the patients with secondary resistance, even after failure of second-line therapy. Grade 3/4 hematologic toxicities included neutropenia (18.1%) and febrile neutropenia (0.3%), and non-hematologic toxicities were tolerable.

Conclusion

Gemcitabine and vinorelbine combination chemotherapy in anthracycline- and taxane-pretreated advanced breast cancer was effective and tolerable.

Citations

Citations to this article as recorded by  
  • Gemcitabine and Vinorelbine Combination Chemotherapy in Taxane-Pretreated Patients with Metastatic Breast Cancer: A Phase II Study of the Kinki Multidisciplinary Breast Oncology Group (KMBOG) 1015
    Jun Yamamura, Norikazu Masuda, Daigo Yamamoto, Shigeru Tsuyuki, Masahide Yamaguchi, Satoru Tanaka, Junji Tsurutani, Shinya Tokunaga, Katsuhide Yoshidome, Makiko Mizutani, Toyokazu Aono, Asako Ooe, Hirokazu Tanino, Nobuki Matsunami, Hiroyuki Yasojima, Taka
    Chemotherapy.2017; 62(5): 307.     CrossRef
  • Phase II study of gemcitabine and vinorelbine as second- or third-line therapy in patients with primary refractory or platinum-resistant recurrent ovarian and primary peritoneal cancer by the Korean Cancer Study Group (KCSG)_KCSG GY10-10
    Sook Hee Hong, Soohyeon Lee, Hoon-Gu Kim, Hyo Jin Lee, Kyung Hae Jung, Sang-Cheol Lee, Na-Ri Lee, Jina Yun, In Sook Woo, Kyong Hwa Park, Kyoung-ha Kim, Ho Young Kim, Sun Young Rha, Jae Ho Byun
    Gynecologic Oncology.2015; 136(2): 212.     CrossRef
  • ‘Who’, ‘when’ and ‘how’ in re-irradiation of recurrent painful bone metastases
    Florence Mok, Kenneth Li, Rebecca Yeung, Kam-Hung Wong, Brian Yu, Erin Wong, Gillian Bedard, Edward Chow
    Journal of Bone Oncology.2013; 2(1): 33.     CrossRef
  • Gemcitabine in combination with vinorelbine in elderly patients with anthracycline- and taxane-pretreated metastatic breast cancer
    Ningning Dong, Mingyu Wang, Huiqing Li, Yongchun Cui, Qisen Guo
    Cancer Chemotherapy and Pharmacology.2012; 69(5): 1315.     CrossRef
  • Safety and efficacy of gemcitabine plus cisplatin combination in pretreated metastatic breast cancer patients
    Luiz Gustavo Oliveira Brito, Jurandyr Moreira de Andrade, Thiago Lins-Almeida, Fábio Eduardo Zola, Mariana Novaes Pinheiro, Heitor Ricardo Cosiski Marana, Daniel Guimarães Tiezzi, Fernanda Maris Peria
    Medical Oncology.2012; 29(1): 33.     CrossRef
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Phase II Study of Gemcitabine and Vinorelbine as Second-Line Chemotherapy in Non-Small Cell Lung Cancer
Yoon Jae Kim, Joo Hyuk Sohn, Chul Kim, Yong Tai Kim, Hai Jin Kim, Joong Bae Ahn, Se Kyu Kim, Joon Chang, Nae Choon Yoo, Joo Hang Kim, Jae Yong Cho
Cancer Res Treat. 2003;35(4):294-298.   Published online August 31, 2003
DOI: https://doi.org/10.4143/crt.2003.35.4.294
AbstractAbstract PDF
PURPOSE
With the increased use of chemotherapy for non small cell lung cancer (NSCLC), a growing group of patients can now be considered for second-line chemotherapy. However, guidelines for the second line treatment remain to be developed. The objective of this study was to evaluate the efficacy and safety of the gemcitabine and vinorelbine combination therapy in patients with advanced NSCLC, pretreated with taxane and platinum based regimens. Gemcitabine has already demonstrated activity in this patient group, with the combination therapy having been reported to be well tolerated in previous phase I/II studies.
MATERIALS AND METHODS
Forty two patients with advanced NSCLC (stages III/IV), having received prior taxane and platinum based chemotherapy, with an ECOG performance status (PS) 0~2, and unimpaired hematopoietic and organ function, were treated with vinorelbine, 20 mg/m2, followed by gemcitabine, 1, 000 mg/m2, both administered on days 1, 8 and 15, every 4 weeks.
RESULTS
Out of the 42 patients enrolled, 41 were evaluable for their response, and all 42 for their toxicity. The patient's characteristics were as follows; median age=60 years (42~73), median PS=1 (range 0~2), a gender ratio 31: 11 males/females, with stages IIIA, IIIB and IV in 3, 14 and 25 cases. The objective responses included a partial response (PR) 8/41 (19.5%), a stable disease 15/41 (36.6%) and a progressive disease 18/41 (43.9%). The median time-to progression (TTP) and survival were 4 months, ranging from 2 to 14 months, and 8 months, ranging from 2 to 17+ months, respectively. Grade 3 neutropenia was seen in 19% of the patient, and there was no grade 4 neutropenia or episodes of febrile neutropenia. No grade 4 thrombocytopenia or other grade 3/4 non-hematological toxicities were observed.
CONCLUSION
The combination of gemcitabine/vinorelbine is active and well tolerated in patients with advanced NSCLC having failed prior taxane/platinum therapy.
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Effect of Vinorelbine, Ifosfamide and Cisplatin Combination Chemotherapy in Stage III-IV Non-Small-Cell Lung Cancer
Young Chul Kim, So Young Lee, Hong Joo Cho, Jung A Kim, So Hyang Song, Chi Hong Kim, Hoon Kyo Kim, Meyung Im Ahn, Jin Young You, Sung Whan Kim, Deng Gon Cho, Kyu Do Cho, Jin Hyung Kang
Cancer Res Treat. 2002;34(5):352-356.   Published online October 31, 2002
DOI: https://doi.org/10.4143/crt.2002.34.5.352
AbstractAbstract PDF
PURPOSE
To evaluate the response rates, toxicitiesy, and survival rates, to vinorelbine (Navelbine(R)), cisplatin and ifosfamide combination chemotherapy, of the patients with inoperable NSCLC (stage III and IV), who received vinorelbine (Navelbine(R)), cisplatin, ifosfamide combinationthe mentioned chemotherapy every 4 weeks.
MATERIALS AND METHODS
This study included 26 patients with inoperable NSCLC (stage III and IV), who attended St. Vincent's Hospital Bbetween April 1999 and December 2001, 26 patients were included at St.Vincent's Hospital. The chemotherapy regimen consisted of vinorelbine (25 mg/m2 on days 1 and 8), ifosfamide (1,500 mg/m2 on days 1- and 2 with mesna), and cisplatin (30 mg/m2 on days 1- to 3). The cycles were administered every 4 weeks. A 25% reduction in the doses reduction was applied into subsequent courses if there werewas grade 3~4 neutropenia.
RESULTS
The median age was 63 (range, 44~73) years and the male : to female ratio was 19 : 7. One patient had stage IIIa, 6 had stage IIIb and 19 had stage IV. Twenty two patients had an ECOG performance status of 0 or 1, andwith 4 hadhave one of 2. Eighteen of the patients had adenocarcinoma, 7 had squamous cell carcinomas, and 1 had an undifferentiated NSCLC. Two patients were innot able to be evaluatedble due to follow-up loss. Among Of the 24 patients able to be evaluatedble patients, 1 patient had a complete response and 9 patients hada partial responses, and thewith an overall response rate wasof 41.7%. During a total of 104 cycles, grade 3 neutropenia occurred in 29%, grade 4 neutropenia in 12%, grade 3~4 thrombocytopenia in 4%, grade 3 anemia in 11%, and grade 3~4 mucositis in 2%. The mean time to progression was 6.4 months (range 1~13) and the median overall survival was 10 months (range 1.5~32).
CONCLUSION
The combination of vinorelbine, ifosfamide and cisplatin, in the dose and schedule employed in this study, shows an response rate of 41.7%, but, because grade 3- or 4 neutropenia occurred in 41%, a careful investigation is needed.
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Combination Chemotherapy with Mitomycin C, Vinorelbine, and Cisplatin (MVrP) in Patients with Advanced Non-Small Cell Lung Cancer
Hun Gu Kim, Gyeong Won Lee, Dae Hwan Lee, In Gyu Hwang, Ki Shik Shim, Won Sup Lee, Jong Deog Lee, Joung Soon Jang, Young Sil Hwang, Jong Seok Lee
Cancer Res Treat. 2001;33(5):377-384.   Published online October 31, 2001
DOI: https://doi.org/10.4143/crt.2001.33.5.377
AbstractAbstract PDF
PURPOSE
A phase II study was conducted in patients with advanced non-small cell lung cancer (NSCLC) in order to evaluate the efficacy and toxicity of the combination chemotherapy regimen of mitomycin C, vinorelbine, and cisplatin (MVrP).
MATERIALS AND METHODS
Between June 1996 and December 2000, fifty-nine patients with unresectable stage IIIB to IV, pathologically documented NSCLC were enrolled in this study. One cycle consisted of mitomycin C 10 mg/m2 i.v. day 1, vinorelbine 30 mg/m2 i.v. days 1 & 15, and cisplatin 80 mg/m2 i.v day 1 and the next cycle consisted of vinorelbine 30 mg/m2 i.v. days 29 & 43, and cisplatin 80 mg/m2 i.v day 29. Each cycle was alternated and treatments were repeated every 8 weeks.
RESULTS
We were able to evaluate fifty-three of 59 patients. Objective responses were seen in 22 (41.5%) patients (CR 0%, PR 41.5%). The median duration of response was 13.7 weeks and the median time to progression was 17.7 weeks. The median overall survival was 45.6 weeks. There was a significantly longer survival seen in responders (p=0.041). The toxicities of this regimen were acceptable without treatment related toxic death.
CONCLUSION
This study suggests that a combination regimen of mitomycin C, vinorelbine, and cisplatin is relatively effective and well tolerated for the treatment of advanced NSCLC.
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Phase II Trial of Vinorelbine and Cisplatin Chemotherapy in Advanced Non-Small Cell Lung Cancer
Yo Han Joh, Tae You Kim, Im Il Na, Do Youn Oh, Byung Su Kim, Jee Hyun Kim, Do Yeun Kim, Se Hoon Lee, Chul Gyu Yoo, Choon Taek Lee, Young Whan Kim, Dae Seog Heo, Yung Jue Bang, Sung Koo Han, Young Soo Shim, Noe Kyeong Kim
Cancer Res Treat. 2001;33(5):373-376.   Published online October 31, 2001
DOI: https://doi.org/10.4143/crt.2001.33.5.373
AbstractAbstract PDF
PURPOSE
Platinum-based chemotherapy has conferred a modest but significant survival benefit and the introduction of newer drugs has led to achieve higher response rate in patients with advanced non-small cell lung cancer (NSCLC). We performed a phase II trial in order to evaluate the efficacy and toxicity of combination chemotherapy with vinorelbine (Navelbine) and cisplatin in advanced NSCLC.
MATERIALS AND METHODS
Patients with previously untreated, unresectable stage IIIB or IV NSCLC with measurable lesion (s) were eligible for entry into the study. NP chemotherapy consisted of intravenous vinorelbine 25 mg/m2, on day 1 and 8, and intravenous cisplatin 80 mg/m2 on day 1; this cycle was repeated every three weeks.
RESULTS
A total of 33 patients were enrolled in the study between July 1999 and Feb 2000. Of the 30 patients deemed eligible for analysis, thirteen patients achieved a partial response and thirteen showed a stable disease. The overall response rate was 43.3%. The median duration of response was 5.7 months (95% CI: 2.8~8.5 months). The median time to progression was 7.6 months (95% CI: 5.5~9.7 months) and the overall median survival time was 15.1 months (95% CI: 9.8~20.4 months) in the intent-to-treat analysis. Chemotherapy-related grade 3 or 4 toxicities were anemia in 1.5%, leukopenia in 4.5%, nausea/vomiting in 2.3%, alopecia in 13.3%, and neurotoxicity in 3.3%.
CONCLUSION
The combination of vinorelbine and cisplatin chemotherapy seems to be active and fairly tolerable in patients with advanced NSCLC.

Citations

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  • Clinical research on the efficacy of self-made sichongsan in combination with gefitinib on NSCLC patients with EGFR mutation
    Yibo Zhao, Yu Dong, Shu Xing, Xueqi Fu
    European Journal of Inflammation.2018;[Epub]     CrossRef
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Combination Chemotherapy with Vinorelbine and Ifosfamide in Patients with Advanced Non-Small Cell Lung Cancer
Seong Geun Kim, Sung Hyun Kim, Hyuk Chan Kwon, Kee Hyun Lee, Jae Seok Kim, Hyo Jin Kim
J Korean Cancer Assoc. 2001;33(2):163-167.
AbstractAbstract PDF
PURPOSE
We conducted a phase II study of vinorelbine and ifosfamide combination chemotherapy in patients with advanced or recurrent non-small cell lung cancer (NSCLC) to evaluate response rate, response duration, and toxicities of this regimen.
MATERIALS AND METHODS
From June 1998 to March 2000, twenty seven patients with advanced or recurrent non- small cell lung cancer (stage IIIB and IV) who had no prior systemic chemotherapy were enrolled in this study. All patients were treated with vinorelbine and ifosfamide combination chemotherapy (vinorelbine 25 mg/m2 i.v. days 1 & 8, and ifosfamide 2 g/m2 i.v. days 1~3 with Mesna 1600 mg/m2). Each cycle was repeated every 21 days.
RESULTS
All twenty seven patients were eligible and assessable. Age ranged from 41 to 72 (median 57 years). 14 patients were male and 13 were female. Overall response rate was 33.3%. One complete response (3.7%) and 8 partial responses (29.6%) were observed. Stable disease was 15 (55.6%) and progressive disease was 3 (11.1%). Overall median survival duration was 7.8 months. The median progression-free and response durations were 6.6 months and 3.5 months respectively. World Health Organization grade 3 to 4 neutropenia occurred in 6.5%. Nonhematologic toxicities including nausea/vomiting, nephropathy and hepatopathy were generally grade 1 or 2.
CONCLUSION
The combination chemotherapy with vinorelbine and ifosfamide in the patients with advanced or recurrent non-small cell lung cancer can be considered as an effective and safe treatment.
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Combination Chemotherapy with Cisplatin and Vinorelbine in Patients with Non-Small-Cell Lung Cancer
Kee Won Kim, Suk Young Park, Ji Won Suhr, Seung Joon Kim, Dong Hoen Yang, Eun Hee Lee, Kyung Shick Lee
J Korean Cancer Assoc. 2000;32(5):911-917.
AbstractAbstract PDF
PURPOSE
To determine the therapeutic effect and toxicities of cisplatin and vinorelbine combination chemotherapy in patients with inoperable non-small-cell lung cancer.
MATERIALS AND METHODS
Between Jan 1998 and Dec 1999, 28 patients with inoperable non- small-cell lung cancer were treated with cisplatin and vinorelbine combination chemotherapy as induction treatment. A combination of vinorelbine 25 mg/m2 day 1,8 and cisplatin 60 mg/m2 day 1 were given and repeated every 3 weeks. Then we assessed response and toxicity according to WHO grades.
RESULTS
According to response criteria, there were 1 complete response, 12 partial response (42.9%), 12 stable disease (42.9%), and 3 progression (10.7%). The median survival was 12 months. According to toxicity grades, 24 grade 3 myelosuppression (24.7%), 12 grade 4 myelo suppression (10.7%), 6 grade 3 and 4 constipation (6.1%), and mild 7 (7.2%) thrombophlebitis were experienced in evaluable 97 cycles. There was no other clinically severe toxicity.
CONCLUSION
These results suggest that combination chemotherapy with cisplatin and vinorelbine in patients with inoperable non-small-cell lung cancer was effective and safe.
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Venous Irritation Incidence Associated with Vinorelbine Tartrate Injection Time
Kyung Wook Hur, Jin Eui Jung, Jae Hong Seo, Cheul Won Choi, Byung Soo Kim, Sang Won Shin, Yeul Hong Kim, Jun Suk Kim
J Korean Cancer Assoc. 2000;32(4):699-704.
AbstractAbstract PDF
PURPOSE
This study was to determine the incidence and severity of venous irriation in patients receiving vinorelbine tartrate (Navelbine ) in combination chemotherapy. MATERIAL AND METHODS: Twenty four patients histologically confirmed non-small cell lung cancer were enrolled in this study who receiving vinorelbine in combination chemotherapy through a peripheral vein from Oct. 1997 to Mar. 1999 with retrospective study design method. One group was 6~10 minutes infusion rate, the other was 10~20 minutes infusion rate with the same free-flow intravenous infusion.
RESULTS
A total of 126 infusions were observed in this study. Sixty-two infusions were admi nistered at the 6~10 minutes, and 64 infusions were administered at the 10~20 minutes. The incidence of any venous irritation was 3.2% (2/62) in the group that received the infusion in 6~10 minutes and 10.9% (7/64) in 10~20 minutes (p=0.164), so we could not acquire any statistical significance. However the incidence of severe venous irritation (grade 3, 4) was 0% (0/62) in 6~10 minutes infusion group and 9.4% (6/64) in 10~20 minutes infusion group. There was a significant difference between two groups (p=0.028) CONCLUSION: Our results suggest that venous irritation associated with vinorelbine tartrate infusion can be reduced by shorter duration of administration and vinorelbine tartrate might be recom mended to administer at 6~10 minutes infusion in clinical practice.
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A Phase II Study with Vinorelbine and Carboplatin in Patients with Advanced Non-small Cell Lung Cancer
Jong Lyul Kim, Bong Seog Kim, Byoung Ju Na, Mi Jin So, Jin Han Lee, Oh Young Chung, Gwi Lae Lee, Yong Ho Roh
J Korean Cancer Assoc. 2000;32(4):690-698.
AbstractAbstract PDF
PURPOSE
To evaluate the efficacy and safety of vinorelbine and carboplatin in advanced non- small-cell lung cancer (NSCLC).
MATERIALS AND METHODS
Between August 1998 and July 1999, 25 patients were enrolled. The median age was 68 (range, 46~77) years and male:female ratio was 23:2. Two patients had stage IIIa, 15 had stage IIIb and 8 had stage IV. Sixteen patients had ECOG performance status of 0 or 1 and 9 had 2 or 3. Sixteen patients had squamous cell carcinoma, 8 had adenocarcinoma and 1 had undifferentiated NSCLC. Treatment consists of intravenous carboplatin 400 mg/m2 on day 1 and vinorelbine 25 mg/m2 on days 1 and 8. The treatment was repeated every 28 days.
RESULTS
Twenty-three of 25 patients were evaluable. Partial response were observed in 11 patients. The overall response rate was 48% (95% confidence interval: 27~69%) and the median response duration was 19 (range 7 ~44 ) weeks. The median survival of 25 patients was 52 (range 3~53 ) weeks. Toxicities were evaluated by WHO criteria. During a total of 108 cycles, granulocytopenia worse than WHO grade 3 occurred in 2%, thrombocytopenia in 4% and anemia in 10%, respectively. Treatment-related death occurred in 1 patient due to sepsis during cytopenic period. Non-hematologic toxicity was minor and easily controlled.
CONCLUSION
A combination chemotherapy of intravenous vinorelbine and carboplatin has relatively high activity with acceptable toxicities in patients with advanced NSCLC.
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Efficacy of Combination Chemotherapy with Vinorelbine, Ifosfamide, and Cisplatin in Patients with Advanced Non-Small Cell Lung Cancer
Heung Moon Chang, Jung Ae Lee, Jin Seok Ahn, In Sook Woo, Young Iee Park, Jee Woong Son, Seung Joon Lee, Dong Kyu Kim, Eun Kyung Mo, Myung Jae Park, Myung Goo Lee, In Gyu Hyun, Ki Suck Jung, Young Suk Park
J Korean Cancer Assoc. 2000;32(3):612-618.
AbstractAbstract PDF
PURPOSE
To evaluate the efficacy and toxicity of combination chemotherapy with vinorelbine, ifosfamide, and cisplatin in patients with advanced non-small cell lung cancer.
MATERIALS AND METHODS
Patients with unresectable, pathologically proven non-small cell lung cancer who had no prior chemotherapy were eligible. Patients received vinorelbine (25 mg/m2, iv., D1 & 8), ifosfamide (1.5 g/m2, iv., D1-3 with mesna), and cisplatin (60 mg/m2, iv., D1). The treatment was repeated every 3 weeks.
RESULTS
Between degrees Ctober, 1997 and June, 1999, 26 patients were enrolled. Median age was 61. 1 patient had stage IIIA, 13 had stage IIIB, and 12 had stage IV. Patients with adendegrees Carcinoma were 15, squamous cell carcinoma were 11. Of 22 evaluable patients, objective responses were observed in 9 patients (response rate: 40.9%, CR: 1 (4.5%), PR 8 (36.4%)). Median duration of response was 48 weeks. Median overall survival was 52 weeks. Grade 3-4 leukopenia was observed in 10.2% of the 88 courses. There was 1 death related to febrile neutropenia. Non- hematologic toxicities were mild.
CONCLUSION
We concluded that combination chemotherapy with vinorelbine, ifosfamide, and cisplatin was effective and tolerable in patients with advanced non-small cell lung cancer, and phase III randomized trial is needed to compare this regimen to other cisplatin-based regimens.
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Combination Chemotherapy of Vinorelbine and Epirubicin ( VE ) in Patients with Advanced Breast Cancer
S M Bang, H S Hong, K H Cha, T H Lee, J A Lee, Y S Park, E K Cho, D B Shin, J H Lee
J Korean Cancer Assoc. 2000;32(2):244-252.
AbstractAbstract PDF
PURPOSE
This study was performed to evaluate the efficacy and toxicity of vinorelbine in combination with epirubicin as a first-line chemotherapy in patients with advanced breast cancer as well as a second-line chemotherapy in refractory patients after failing to first-line chemotherapy.
MATERIALS AND METHODS
Between March 1997 and July 1999, thirty-seven patients were enrolled. Vinorelbine 25 mg/m2 intravenously (IV) on days 1 and 8, and epirubicin 50 mg/m2 IV on day 1 were given every 3 weeks. Among the evaluable 34 patients, 25 patients received VE chemotherapy as a ""first-line chemotherapy"". 4 patients had initially systemic metastasis, 2 patients relapsed after operation and 19 patients relapsed after adjuvant chemotherapy. Nine patients had progressive diseases after one or more palliative regimens. Among the 9 patients, 1 patient showed the progression during the adjuvant chemotherapy. The median age of the patients was 49 years (range; 31~64), and 68% of patients were premenopausal. Dominant sites of metastasis were viscera in 82% and non-viscera (soft tissue, lymph nodes and bone) in 18%.
RESULTS
Overall response rates (RR) were 64% in first-line group. There was no responder in second-line group. Six patients without any prior chemotherapy obtained 2 CR and 3 PR (RR; 83%), while pre-treated 28 patients showed 1 CR and 10 PR (RR; 39%). Among the second-line group, 6 patients had been exposed to anthracycline. Median number of chemotherapy cycle was 3.5 (2~7). Total 135 cycles of therapy were evaluable for toxicity. The most common dose-limiting toxicity was myelosuppression, mainly leukopenia in 58 cycles (43%). Grade 3 or 4 leukopenia were observed in 10 cycles (7%), of which 3 cycles were associated with infection requiring hospitalization. Anemia were observed in 42 cycles (31%), mostly grade 1 or 2 (28%). The most common non-hematologic toxicity was alopecia (91%) followed by phlebitis (41%). There was no therapy-related mortality.
CONCLUSION
Vinorelbine and epirubicin combination showed significant activity as a first-line regimen in advanced breast cancer. The combinaton showed no activity in patients pretreated with other palliative regimen.
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The Effect of Combination Chemotherapy with Vinorelbine, Carboplatin, and Ifosfamide in Patients with Advanced Non-Small Cell Lung Cancer
Young Woo Lee, Baek Yeol Ryoo, Tae You Kim, Bong Seog Kim, Yeon Hee Park, Hyun Ju Hong, Jin Young Kwag, Sang Won Lee, Yoon Koo Kang
J Korean Cancer Assoc. 1999;31(6):1227-1235.
AbstractAbstract PDF
PURPOSE
Despite recent advances in chemotherapy, the treatment outcome of advanced non-small cell lung cancer (NSCLC) remains poor and NSCLC is still the predominant source of cancer-related mortality in worldwide. Thus, we evaluated the efficacy and safety of a combination chemotherapy with vinorelbine, carboplatin, and ifosfamide (NCI) in advanced NSCLC patients.
MATERIALS AND METHODS
A total of 26 patients was enrolled in this study between December 1997 and June 1998. All entered patients were treated with NCI combination chemotherapy (vinorelbine 25 mg/m2/day i.v. days 1 and 8; carboplatin 300 mg/m2/day i.v. day 1; ifosfamide 3 g/m2/day i.v. day I; and mesna 2.4 g/m2/day i.v. day 1 after completion of ifosfamide infusion, treatment repeated every 4 weeks).
RESULTS
Among 26 patients, 23 patients were evaluable. Nine out of 23 evaluable patients had a partial response (response rate 39%; 95% confidence interval 19~59%). The median survival of the total 23 evaluable patients was 7.4 (range; 3~9.3+) months. The median progression-free survival was 2.8 (range; 0~7.7+) months. Among total 70 cycles of chemotherapy, leukopenia of grade II or more was observed in 6%, and tbrombo- cytopenia of grade II or more in 1%. There was no treatment-related death. Main non-hematologic toxicities were nausea/vomiting, stomatitis and peripheral phlebitis, almost of which were tolerable.
CONCLUSION
NCI chemotherapy seemed to be moderately active and well tolerated in patients with advanced NSCLC.
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A Phase 2 Study with Vinorelbine and Ifosfamide in the Inoperable Non - small Cell Lung Cancer
Moon Hee Lee, Young Jin Yoo, Soo Mi Bang, Gyung Hae Joung, Hyo Jin Kim, Dong Bok Shin, Soon Nam Lee, Seong Rok Kim, Dae Seog Heo, Yung Jue Bang, Noe Kyeong Kim
J Korean Cancer Assoc. 1999;31(5):972-978.
AbstractAbstract PDF
PURPOSE
A phase II study of vinorelbine and ifosfamide combination chemotherapy in patients with advanced or recurrent non-small cell lung cancer (NSCLC) was conducted to assess response rate, response duration, and toxicites.
MATERIALS AND METHODS
Patients with advanced NSCLC who had no prior systemic chemotherapy were eligible. They have no central nervous system metastasis and recurrent or progressive disease after surgery or radiotherapy. Each cycle consisted of vinorelbine 25 mg/m' i.v. days 1 & 8, and ifosfamide 2 g/m i.v. days 1, 2 & 3 with Mesna and treatments were repeated every 21 days.
RESULTS
Forty patients with advanced or recurrent NSCLC were treated at multi center between March, 1997 and March, 1998. Six patients were not evaluable because five patients refused therapy after the first course and one patient was protocol violation. Of 34 evaluable patients, objective responses were seen in 11 (32.4%) patients (CR 0%, PR 32.4%). The median duration of response was 16.4 weeks. The median overall survival was 9.5 months. The toicities of this regimen were acceptable without treatment related toxic death.
CONCLUSION
We concluded that combination regimen of vinorelbine and ifosfamide was effective and tolerable in the treatment of advanced non-small cell lung cancer.
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Cancer Res Treat : Cancer Research and Treatment
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