Cancer Research and Treatment

Original Articles

An Open-Label, Randomized, Parallel, Phase III Trial Evaluating the Efficacy and Safety of Polymeric Micelle-Formulated Paclitaxel Compared to Conventional Cremophor EL-Based Paclitaxel for Recurrent or Metastatic HER2-Negative Breast Cancer: In Hae Park, Joo Hyuk Sohn, Sung Bae Kim, Keun Seok Lee, Joo Seop Chung, Soo Hyeon Lee, Tae You Kim, Kyung Hae Jung, Eun Kyung Cho, Yang Soo Kim, Hong Suk Song, Jae Hong Seo, Hun Mo Ryoo, Sun Ah Lee, So Young Yoon, Chul Soo Kim, Yong Tai Kim, Si Young Kim, Mi Ryung Jin, Jungsil Ro; Cancer Res Treat. 2017;49(3):569-577. Published online September 12, 2016; DOI: https://doi.org/10.4143/crt.2016.289

Purpose
Genexol-PM is a Cremophor EL–free formulation of low-molecular-weight, non-toxic, and biodegradable polymeric micelle-bound paclitaxel. We conducted a phase III study comparing the clinical efficacy and toxicity of Genexol-PM with conventional paclitaxel (Genexol).
Materials and Methods
Patients were randomly assigned (1:1) to receive Genexol-PM 260 mg/m² or Genexol 175 mg/m² intravenously every 3 weeks. The primary outcome was the objective response rate (ORR).
Results
The study enrolled 212 patients, of whom 105 were allocated to receive Genexol-PM. The mean received dose intensity of Genexol-PM was 246.8±21.3 mg/m² (95.0%), and that of Genexol was 168.3±10.6 mg/m² (96.2%). After a median follow-up of 24.5 months (range, 0.0 to 48.7 months), the ORR of Genexol-PM was 39.1% (95% confidence interval [CI], 31.2 to 46.9) and the ORR of Genexol was 24.3% (95% CI, 17.5 to 31.1) (p_{non-inferiority}=0.021, p_superiority=0.016). The two groups did not differ significantly in overall survival (28.8 months for Genexol-PM vs. 23.8 months for Genexol; p=0.52) or progression-free survival (8.0 months for Genexol-PM vs. 6.7 months for Genexol; p=0.26). In both groups, the most common toxicities were neutropenia, with 68.6% occurrence in the Genexol-PM group versus 40.2% in the Genexol group (p < 0.01). The incidences of peripheral neuropathy of greater than grade 2 did not differ significantly between study treatments.
Conclusion
Compared with standard paclitaxel, Genexol-PM demonstrated non-inferior and even superior clinical efficacy with a manageable safety profile in patients with metastatic breast cancer.

Citations

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Clinical Usefulness of Hydromorphone-OROS in Improving Sleep Disturbances in Korean Cancer Patients: A Multicenter, Prospective, Open-Label Study: Seong Hoon Shin, Ho Sup Lee, Yang Soo Kim, Young Jin Choi, Sung Hyun Kim, Hyuk Chan Kwon, Sung Yong Oh, Jung Hun Kang, Chang Hak Sohn, Sang Min Lee, Jin Ho Baek, Young Joo Min, Choongrak Kim, Joo Seop Chung; Cancer Res Treat. 2014;46(4):331-338. Published online July 21, 2014; DOI: https://doi.org/10.4143/crt.2013.130

Abstract PDF PubReader ePub

Purpose
To evaluate the efficacy of hydromorphone-OROS (HM-OROS) in reducing sleep disturbance and relieving cancer pain. Materials and Methods One hundred twenty cancer patients with pain (numeric rating scale [NRS] ≥ 4) and sleep disturbance (NRS ≥ 4) were evaluated. The initial HM-OROS dosing was based on previous opioid dose (HM-OROS:oral morphine=1:5). Dose adjustment of the study drug was permitted at the investigator’s discretion. Pain intensity, number of breakthrough pain episodes, and quality of sleep were evaluated. Results A total of 120 patients received at least one dose of HM-OROS; 74 of them completed the final assessment. Compared to the previous opioids, HM-OROS reduced the average pain NRS from 5.3 to 4.1 (p < 0.01), worst pain NRS from 6.7 to 5.4 (p < 0.01), sleep disturbance NRS from 5.9 to 4.1 (p < 0.01), incidence of breakthrough pain at night from 2.63 to 1.53 times (p < 0.001), and immediate-release opioids use for the management of breakthrough pain from 0.83 to 0.39 times per night (p = 0.001). Of the 74 patients who completed the treatment, 83.7% indicated that they preferred HM-OROS to the previous medication. The adverse events (AEs) were somnolence, asthenia, constipation, dizziness, and nausea. Conclusion HM-OROS was efficacious in reducing cancer pain and associated sleep disturbances. The AEs were manageable.

Citations

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Case Report

Successful Chemotherapy Following Autologous Stem Cell Transplantation in Multiple Myeloma and Multi-organ Dysfunction with Infiltration of Eosinophils: A Case Report: Ho Sup Lee, Lee Chun Park, Seong Hoon Shin, Sang Uk Lee, Hee Kyung Chang, Bang Huh, Gyoo Sik Jung, Mi Hyang Kim, Yang Soo Kim; Cancer Res Treat. 2011;43(3):199-203. Published online September 30, 2011; DOI: https://doi.org/10.4143/crt.2011.43.3.199

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Eosinophils are derived from hematopoietic stem cells. Peripheral blood eosinophilia is defined as an absolute eosinophil count of > or =0.5x10(9)/L. Eosinophilia is classified into primary or clonal eosinophilia, secondary eosinophilia, and idiopathic categories including idiopathic hypereosinophilic syndrome. Both hematopoietic and solid neoplasms may be associated with peripheral blood eosinophilia, but multiple myeloma is rarely associated with eosinophilia. We now report the case of a 31-year-old man with multiple myeloma associated with marked eosinophilia who developed multiple organ dysfunction with infiltration of eosinophils. He recovered after treatment with chemotherapy followed by autologous stem cell transplantation.

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Subepidermal Bullous Dermatosis Associated With IgA Multiple Myeloma
Qiang Zhou, Hao Jiang, Kejian Zhu, Rui Han, Hao Cheng
The American Journal of Dermatopathology.2013; 35(3): e49. CrossRef

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Original Article

Clinical Correlation between Brain Natriutetic Peptide and Anthracyclin-induced Cardiac Toxicity: Ho Sup Lee, Chang Bae Son, Seong Hoon Shin, Yang Soo Kim; Cancer Res Treat. 2008;40(3):121-126. Published online September 30, 2008; DOI: https://doi.org/10.4143/crt.2008.40.3.121

Abstract PDF PubReader ePub

Purpose

Anthracycline can effectively treat hematologic malignancies, but has significant risk of cardiotoxicity. We measured the clinical correlation between brain natriuretic peptide (BNP) and anthracycline-induced cardiotoxicity.

Materials and Methods

Between March 2005 and March 2007, 86 patients with acute leukemia, malignant lymphoma, or multiple myeloma receiving systemic chemotherapy with anthracycline were enrolled in the Department of Hemato-oncology, Kosin University Gospel Hospital. We investigated the relationship between BNP level and cardiotoxicity through echocardiography, electrocardiography, BNP levels, and symptoms of heart failure at each chemotherapy cycle.

Results

Of the 86 participants (mean age, 48.5 years; range 20~65 years), cardiotoxicity developed in 21 patients (24.4%), with 2 patients showing arrhythmia only, 17 patients with transient aspects of heart failure, and 2 patients with chronic heart failure. Cardiotoxicity related to serum BNP level, age, cumulative dose of anthracycline, accompanying chronic disease, and elevated level of troponin-I. Heart failure was more common if BNP levels reached 100 pg/ml at least once.

Conclusions

The clinical correlation between BNP and cardiotoxicity was significant in patients with systemic anthracycline chemotherapy. A prospective clinical trial will be needed to identify the causal relationship between serum BNP level and cardiotoxicity.

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Case Report

Intestinal Perforation in Colorectal Cancers Treated with Bevacizumab (Avastin®): Young Il Choi, Seung Hyun Lee, Byung Kwon Ahn, Sung Uhn Baek, Seun Ja Park, Yang Soo Kim, Seong Hoon Shin; Cancer Res Treat. 2008;40(1):33-35. Published online March 31, 2008; DOI: https://doi.org/10.4143/crt.2008.40.1.33

Abstract PDF PubReader ePub

Bevacizumab is a monoclonal antibody that targets vascular endothelial growth factor (VEGF), and it has shown promise as a clinical agent against metastatic colorectal cancer, and particularly in combination with chemotherapy. Bowel perforation is a known risk that's associated with bevacizumab use, but the etiology is unknown. Here we report on two cases of metastatic colorectal cancer in which the patients suffered from intestinal perforation after chemotherapy with bevacizumab. For the first case, a 47 year-old man had rectal cancer with concurrent liver and lung metastasis. He underwent chmotherapy with 5-fluorouracil, irinotecan and bevacizumab. Fever and abdominal pain developed seven days later, and rectal perforation was identified upon exploration 13 days later. For the second case, a 48 year-old woman had sigmoid colon cancer with peritoneal and ovary metastases. After seven days of chemotherapy with 5-fluorouracil, oxaliplatin and bevacizumab, exploratory surgery revealed a perforation at the ileum.

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Original Articles

MINE (mesna, ifosfamide, mitoxantrone, etoposide) Chemotherapy as a Treatment of Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma: Seong Hoon Chang, Yang Soo Kim, Wan Kyu Eo; Cancer Res Treat. 2002;34(2):145-152. Published online April 30, 2002; DOI: https://doi.org/10.4143/crt.2002.34.2.145

Abstract PDF

PURPOSE
The prognosis of non-Hodgkin's lymphoma (NHL) is disappointing for patients who experience primary treatment failure or relapse after an initial response. Patients in relapse may respond again to chemotherapy, however the time to disease progression becomes shorter and eventually the disease becomes resistant. The aim of this study was to evaluate the efficacy and safety of the MINE regimen in the treatment of patients with relapsed or refractory NHL. Material and Methods: Forty-three pretreated patients with a median age of 56 years were enrolled into the study between October 1995 and June 2000. Most patients (60.5%) had a performance status of 0 to 1, and a diffuse large cell subtype (55.8%). Seventy-four percent of patients had stage III or IV disease at the start of MINE treatment. Eighteen (41.9%) patients had complete response, 5 (11.6%) had partial response, and 20 (46.5%) had failed to respond to prior therapy. Ifosfamide 4 g/m2 was divided over 3 days and administered IV over a 1 hour period. Mitoxantrone 8 mg/m2 was administered as a short IV infusion on day 1. Etoposide (65 mg/m2/day) was infused over 1 hour on days 1 to 3. A total of 144 cycles was administered, with a mean of 3.34 cycles per patient (range, 1-8). The mean relative dose intensity was 87.4%.
RESULTS
1) Nine patients achieved a complete response and nine patients achieved a partial response, resulting in an overall response rate of 43.8% of the 41 assessable patients. 2) The median survival time was 6 months (95% CI, 4 to 8 months), and the median time to failure was 5 months (95% CI, 3 to 7 months). 3) A statistically significant association with complete response rates was found for complete response to prior therapy (p=0.049). The significant factors for overall survival were a complete response after MINE chemotherapy and serum 2-microglobulin (p=0.003, p=0.012, respectively). The significant factors for time to treatment failure were a complete response after MINE chemotherapy and serum 2-microglobulin (p=0.003, p=0.044, respectively). 4) The main result of toxicity of MINE was bone marrow suppression.
CONCLUSION
The response to MINE chemotherapy and serum 2-microglobulin were both independent prognostic factors for overall survival and time to treatment failure. As the median time to treatment failure for complete responses was 14 months, the best use of this regimen could be in a strategy that includes prompt consolidation of a complete response with intense chemotherapy, with or without hematopoietic stem cell rescue.

Citations

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Clinical feasibility of oral low-dose etoposide and sobuzoxane for conventional chemotherapy–intolerant lymphoma patients
Akihiro Ohmoto, Shigeo Fuji
Expert Review of Anticancer Therapy.2021; 21(7): 715. CrossRef

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Peripheral Blood Natural Killer Cell Activity and Its Clinical Role in Lymphomas: Own Gyu Uh, Yang Soo Kim, Byung Chae Park; J Korean Cancer Assoc. 1995;27(3):504-513.

Abstract PDF: Purpose
We designed this investigation to evaluate the association of NK activity with vari- ous clinical and laboratory data, and to evaluate whether NK activity can be used as a valuable prognostic factor since there is no systemic review on natural killer cell(NK) activity of peripheral blood in untreated lymphomas in Korea. Method: Forty-eight patients admitted to Dept. of Internal Medicine of Kosin University Hospital from JuL l989 to Feb. 1995 were enrolled. The target of effector cells was K562 cell line and released Cr(51) during 4 hours was counted. Then, NK activity was compared with varous c1inical and laboratary data. We selected International Index, composed of 4 risk groups derived from 5 risk factors, as a prognostic factor to evaluate the value of NK activity, and it was compared with the result of NK activity. The International Index was composed of 4 risk groups: low, low-intermediate, high-intermediate, and high risk groups. Results: 1) The sex ratio of the patients was 1.2: #1 and the median age was 55 years. Diffuse large cell lymphoma was the most common subtype(52.1%). 2) The average NK activity of lymphoma patients was 43.85% and that of normal control was 51.54%, and the difference was significant(F=0.003). 3) The NK activity of the patients was significantly different depending on clinical stage, B symptom or performance status(P=0.003, O.Q33, and 0.016 respectively), but not on age, sex or serum LDH leveL 4) In 4 risk groups, there was progressive decrease in NK activity as the risk increases(P=O. 001), and the differences in NK activity between low and high-intermediate groups and low and high risk groups were all significant(P=0.002 both). 5) NK activity of normal control was significantly different from 3 of 4 risk groups, low-in- termediate, high-intermediate and high risk groups, of patients(P=0.021, 0.001, 0.001 respectively). Concluaion: In previously untreated lymphoma patients, the NK activity was decreased, and NK activity was inversely carrelated with risk status(P=0.001). In conclusion, NK activity may have a prognostic value, and clinical trials with many patients and long-term follow uP as to assess survival are required.

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