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Randomized Phase III Trial of Cisplatin, Epirubicin, Leucovorin, 5-Fluorouracil (PELF) Combination versus 5-fluorouracil Alone as Adjuvant Chemotherapy in Curative Resected Stage III Gastric Cancer
Jae Jin Lee, Si-Young Kim, Im sik Shin, Kyung Sam Cho, Hoong-Zae Joo, Choong Yoon, Yoon Wha Kim, Hwi Joong Yoon
Cancer Res Treat. 2004;36(2):140-145.   Published online April 30, 2004
DOI: https://doi.org/10.4143/crt.2004.36.2.140
AbstractAbstract PDFPubReaderePub
Purpose

The combination of cisplatin, epirubicin, leucovorin and 5-fluorouracil (PELF) administration, as adjuvant chemotherapy after curative resection for gastirc cancer, was compared with 5-fluorouracil (5-FU) administration alone. This paper reports the results of a prospective randomized comparison of the two regimens, PELF and 5-FU.

Methods

From August 1996 to July 1999, 54 patients were selected subsequent to being diagnosed with stage III cancer after a curative resection for gastric cancer. The patients were stratified according to stage IIIA/IIIB and subtotal/total gastrectomy, and then they were randomized into each treatment group, i.e. the PELF or 5-FU alone groups.

Results

54 assessable patients were enrolled in this study: 28 received PELF and 26 received 5-FU alone. 12 patients relapsed in each group and the median follow-up duration was 42 months (range: 10~77 months). The overall survival rate and disease-free survival rate (DFS) were not significantly different between two groups, (5-year survival of PELF vs. 5-FU: 57% vs. 64%, 5-year DFS: 54% vs. 51%). The PELF combination was more toxic in terms of anemia, anorexia, nausea and diarrhea than the 5-FU.

Conclusions

This study showed that the PELF combination, as an adjuvant therapy for gastric cancer after a curative resection, was a less effective treatment, and it had more toxic effects than the 5-FU.

Citations

Citations to this article as recorded by  
  • Multidisciplinary treatment strategy for locally advanced gastric cancer: A systematic review
    Kotaro Sugawara, Yoshikuni Kawaguchi, Yasuyuki Seto, Jean-Nicolas Vauthey
    Surgical Oncology.2021; 38: 101599.     CrossRef
  • The Efficacy and Safety of (Neo)Adjuvant Therapy for Gastric Cancer: A Network Meta-analysis
    Tom van den Ende, Emil ter Veer, Mélanie Machiels, Rosa M. A. Mali, Frank A. Abe Nijenhuis, Laura de Waal, Marety Laarman, Suzanne S. Gisbertz, Maarten C. C. M. Hulshof, Martijn G. H. van Oijen, Hanneke W. M. van Laarhoven
    Cancers.2019; 11(1): 80.     CrossRef
  • Prognostic and Predictive Factors for the Curative Treatment of Esophageal and Gastric Cancer in Randomized Controlled Trials: A Systematic Review and Meta-Analysis
    Tom van den Ende, Emil ter Veer, Rosa M. A. Mali, Mark I. van Berge Henegouwen, Maarten C. C. M. Hulshof, Martijn G. H. van Oijen, Hanneke W. M. van Laarhoven
    Cancers.2019; 11(4): 530.     CrossRef
  • COMplot, A Graphical Presentation of Complication Profiles and Adverse Effects for the Curative Treatment of Gastric Cancer: A Systematic Review and Meta-Analysis
    Tom van den Ende, Frank A. Abe Nijenhuis, Héctor G. van den Boorn, Emil ter Veer, Maarten C. C. M. Hulshof, Suzanne S. Gisbertz, Martijn G. H. van Oijen, Hanneke W. M. van Laarhoven
    Frontiers in Oncology.2019;[Epub]     CrossRef
  • Comparative effectiveness of adjuvant treatments for resected gastric cancer: a network meta-analysis
    Zhaolun Cai, Yiqiong Yin, Yuan Yin, Chaoyong Shen, Jian Wang, Xiaonan Yin, Zhixin Chen, Ye Zhou, Bo Zhang
    Gastric Cancer.2018; 21(6): 1031.     CrossRef
  • Current challenges of metastatic breast cancer
    Bora Lim, Gabriel N. Hortobagyi
    Cancer and Metastasis Reviews.2016; 35(4): 495.     CrossRef
  • Management of Gastroesophageal Junction Tumors
    Matthew P. Fox, Victor van Berkel
    Surgical Clinics of North America.2012; 92(5): 1199.     CrossRef
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  • 7 Crossref
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A Phase II Study of Ifosfamide, Carboplatin, and Epirubicin (ICE) Combination Chemotherapy for Extensive Disease of Small Cell Lung Cancer
Jae Ho Byun, In Sook Woo, Hun Ho Song, Keun Seok Lee, Jin Seok Ahn, Dae Young Jang, Jung Ae Lee, Young Lee Park, Young Suk Park
Cancer Res Treat. 2002;34(6):416-420.   Published online December 31, 2002
DOI: https://doi.org/10.4143/crt.2002.34.6.416
AbstractAbstract PDF
PURPOSE
To evaluate the efficacy and safety of ifosfamide, carboplatin and epirubicin (ICE) combination chemotherapy for extensive disease small cell lung cancer (SCLC) patients, who had received no previous chemotherapy, we performed phase II trial between August 1998 and January 2001.
MATERIALS AND METHODS
The study group comprised of 21 patients. Ifosfamide, 1,500 mg/m2, was given with mesna, 900 mg/m2, intravenously for 12 hours on days 1, 2 and 3, and carboplatin, 4.5 mg/ml/min, for target AUC, and epirubicin, 60 mg/m2, were given intravenously for 90 minutes on day 1. The cycle of treatment was repeated at 4 week intervals.
RESULTS
Twenty-one patients with extensive disease SCLC were treated at Hallym University between August 1998 and January 2001. One patient was unable to be evaluated because of lost to follow-up. Of the 20 patients able to be evaluated, an objective response was observed in 13 (65%). There were no complete responses. The median response duration, time to progression and median overall survival were 15.4, 18.3 and 34 weeks, respectively. Toxicities were acceptable, with dose reduction for myelosuppression necessary in only a minority of the patients. A total of 85 cycles of chemotherapy were given to the patients. The median number of cycles completed was 4. Grade III and IV hematological toxicities included anemia (4.7%), neutropenia (3.5%) and thrombocytopenia (3.5%). Most non-hematological toxicities were grade I or II.
CONCLUSION
These results suggested that ICE combination chemotherapy for extensive disease SCLC is effective, and can be safely administered with acceptable toxicities.
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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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Phase II Study of Ifosfamide, Epirubicin and Cisplatin(IEP) in Patients with Small Cell Lung Cancer
Hwi Joong Yoon, Hyun Joo Park, Si Young Kim, Kyung Sam Cho, Jung Hee Kim, Sung Eon Hong
J Korean Cancer Assoc. 1998;30(4):728-736.
AbstractAbstract PDF
PURPOSE
Although it is well recognized that SCLC is a chemo and radiosensitive tumor, only fraction of treated patients have a complete remission, fewer still have durable remissions. This study was performed to evaluate the clinical effects of IEP chemotherapy in patients with SCLC.
MATERIALS AND METHODS
Patients with histologically proven SCLC who has measurable disease and previously untreated, were eligible. Treatment consisted of ifosfamide 1000 mg/m2 iv infusion for 1 hour on days 1~5 with mesna uroprotection; epirubicin 60 mg/m2 iv on day 1; and cisplatin 20 mg/m2 iv infusion on days 1~5 with hydration; repeated treatment every 4 weeks RESULTS: Twenty four patients(20 males, 4 females) were eligible for response to IEP chemotherapy. The two patients were excluded because one died before evaluating response to chemotherapy and the other had brain metastasis. The median age was 61(range 34-74). Fifteen patients had a limited disease(LD), nine patients had a extensive disease(ED). The overall response rate was 86.4%(CR 36.4%, PR 50%). In LD, response rate was 86.7%(CR 46.7%) and in ED, response rate was 85.7%(CR 14.3%). The median overall survival time was 43.5 weeks. The median survival time of LD and ED was 46.5 weeks and 43.5 weeks respectively. The median time to progression was 20 weeks in responders. The toxicity was moderate. One toxic death was observed. Grade 1 or 2 non-hematologic toxicities consisted of alopecia, nausea and vomiting in all cases, peripheral neuropathy in 3, hematuria in 2, mucositis in 11, and fever/infection in 6. Hematologic toxic effects included leukopenia(> or =grade.3, 16.5%), anemia(> or =grade 3, 1%), and thrombocytopenia(> or =grade 3, 6.8%).
CONCLUSIONS
These results suggest that IEP chemotherapy may be useful as a treatment strategy in small cell lung cancer, but its efficacy is equivalent. The phase III study should be needed.
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