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Randomized Phase III Trial of Irinotecan Plus Cisplatin versus Etoposide Plus Cisplatin in Chemotherapy-Naïve Korean Patients with Extensive-Disease Small Cell Lung Cancer
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Dong-Wan Kim, Hoon-Gu Kim, Joo-Hang Kim, Keunchil Park, Hoon-Kyo Kim, Joung Soon Jang, Bong-Seog Kim, Jin-Hyoung Kang, Kyung Hee Lee, Sang-We Kim, Hun Mo Ryoo, Jin-Soo Kim, Ki Hyeong Lee, Jung Hye Kwon, Jin-Hyuk Choi, Sang Won Shin, Seokyung Hahn, Dae Seog Heo
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Cancer Res Treat. 2019;51(1):119-127. Published online March 12, 2018
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DOI: https://doi.org/10.4143/crt.2018.019
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 Abstract
 PDF Supplementary Material PubReader ePub
- Purpose
This randomized phase III study was designed to compare the efficacy and safety of irinote-can plus cisplatin (IP) over etoposide plus cisplatin (EP) in Korean patients with extensive-disease small-cell lung cancer (SCLC).
Materials and Methods
Patients were randomly assigned to receive IP, composed of irinotecan 65 mg/m2 intravenously on days 1 and 8+cisplatin 70 mg/m2 intravenously on day 1 every 3 weeks, or EP, composed of etoposide 100 mg/m2 intravenously on days 1, 2, 3+cisplatin 70 mg/m2 intravenously on day 1, every 3 weeks for a maximum of six cycles, until disease progression, or until unacceptable toxicity occurred. The primary endpoint was overall survival.
Results
A total of 362 patients were randomized to IP (n=173) and EP (n=189) arms. There were no significant differences between IP and EP arms for the median overall survival (10.9 months vs. 10.3 months, p=0.120) and the median progression-free survival (6.5 months vs. 5.8 months, p=0.115). However, there was a significant difference in response rate (62.4% vs. 48.2%, p=0.006). The pre-planned subgroup analyses showed that IP was associated with longer overall survival in male (11.3 months vs. 10.1 months, p=0.036), < 65 years old (12.7 months vs. 11.3 months, p=0.024), and Eastern Cooperative Oncology Group performance status 0/1 (12.4 months vs. 10.9 months, p=0.040) patient groups. The severity of treatment-related adverse events such as grade 3/4 anemia, nausea and diarrhea was more frequent in patients treated with IP.
Conclusion
The IP chemotherapy did not significantly improve the survival compared with EP chemotherapy in Korean patients with extensive-disease SCLC.
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Citations
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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
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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
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Cancer Res Treat. 2017;49(3):569-577. Published online September 12, 2016
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DOI: https://doi.org/10.4143/crt.2016.289
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Abstract
PDFPubReaderePub
- 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) (pnon-inferiority=0.021, psuperiority=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.
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Citations
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Effect of Dose Escalation with Single Opioid, Fentanyl Matrix in Patients Not Controlling Cancer Pain: A Multicenter, Prospective, Observational Study in Korea
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Sung Ae Koh, Kyung Hee Lee, Mi Jung Kim, Kyu Taek Lee, Seung Woo Park, Seung Hyun Nam, Hun Mo Ryoo
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Cancer Res Treat. 2013;45(4):263-269. Published online December 31, 2013
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DOI: https://doi.org/10.4143/crt.2013.45.4.263
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Abstract
PDFPubReaderePub
- PURPOSE
End-of-dose failure (EOD) is a clinically common observation and many cancer patients increase the frequency of opioid administration. Fentanyl matrix use is known to be effective in patients with chronic cancer pain. To measure the effectiveness of increase in a single dose of fentanyl matrix in patients whose pain was not controlled sufficiently, we perform this study.
MATERIALS AND METHODS
A multi-center, open-label, prospective, observational study was conducted in 30 hospitals in Korea, between August and December 2008.
RESULTS
A total of 452 patients were enrolled; 404 patients completed the study. The mean pain intensity decreased from 5.27 at the first visit to 3.37 at the end of the trial.
There was a significant difference in pain intensity (p < 0.001) between the first and last visits. The percentage of pain intensity difference was 30.1%. The prevalence of EOD at the first visit was 73% from the 452 enrolled patients.
After the use of fentanyl patch, EOD decreased from 73% to 56%. Pain intensity of patients experiencing EOD was 5.64 at the baseline compared to 4.27 in patients without EOD. On final visit, pain intensity in patients with and without EOD was 4.02 and 2.54, respectively. The observed adverse events were mainly nausea, asthenia, constipation and diarrhea.
CONCLUSION
This study demonstrated that increasing dose of fentanyl patch decreased pain intensity and decreased the rate of patients experiencing EOD. Thus, fentanyl patch may be an effective modality in cancer patients whose pain was previously not controlled sufficiently; the side effects were as could be expected with an opioid.
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Clinical Outcome of Rituximab-Based Therapy (RCHOP) in Diffuse Large B-Cell Lymphoma Patients with Bone Marrow Involvement
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Byung Woog Kang, Joon Ho Moon, Yee Soo Chae, Soo Jung Lee, Jong Gwang Kim, Yeo-Kyeoung Kim, Je-Jung Lee, Deok-Hwan Yang, Hyeoung-Joon Kim, Jin Young Kim, Young Rok Do, Keon Uk Park, Hong Suk Song, Ki Young Kwon, Min Kyung Kim, Kyung Hee Lee, Myung Soo Hyun, Hun Mo Ryoo, Sung Hwa Bae, Hwak Kim, Sang Kyun Sohn
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Cancer Res Treat. 2013;45(2):112-117. Published online June 30, 2013
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DOI: https://doi.org/10.4143/crt.2013.45.2.112
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Abstract
PDFPubReaderePub
- PURPOSE
We investigated the clinical outcome of bone marrow (BM) involvement in patients with diffuse large B-cell lymphoma (DLBCL) who received rituximab-based therapy.
MATERIALS AND METHODS
A total of 567 consecutive patients with newly diagnosed DLBCL treated with rituximab-CHOP (RCHOP) between November 2001 and March 2010 were included in the current study. All of the patients underwent a BM study at the initial staging and the clinical characteristics and prognosis of these patients with or without BM involvement were analyzed retrospectively.
RESULTS
The total cohort included 567 patients. The overall incidence of BM involvement was 8.5%. With a median follow-up duration of 33.2 months (range, 0.1 to 80.7 months) for patients who were alive at the last follow-up, the five-year overall survival (OS) and event-free survival (EFS) rate in patients without BM involvement (76.3% and 67.5%, p<0.001) was statistically higher than that in patients with BM involvement (44.3% and 40.1%, p<0.001). In multivariate analysis, among total patients, BM involvement showed a significant association with OS and EFS. In univariate and multivariate analyses, even among stage IV patients, a significant association with worse EFS was observed in the BM involvement group.
CONCLUSION
BM involvement at diagnosis affected the survival of patients with DLBCL who received RCHOP. Although use of RCHOP can result in significant improvement of the therapeutic effect of DLBCL, BM involvement is still a negative prognostic factor of DLBCL patients in the era of rituximab.
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Citations
Citations to this article as recorded by - Combination of Bone Marrow Biopsy and Flow Cytometric Analysis: The Prognostically Relevant Central Approach for Detecting Bone Marrow Invasion in Diffuse Large B-Cell Lymphoma
Haruya Okamoto, Nobuhiko Uoshima, Ayako Muramatsu, Reiko Isa, Takahiro Fujino, Yayoi Matsumura-Kimoto, Taku Tsukamoto, Shinsuke Mizutani, Yuji Shimura, Tsutomu Kobayashi, Eri Kawata, Hitoji Uchiyama, Junya Kuroda
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Maria Joao Baptista, Olga Garcia, Mireia Morgades, Eva Gonzalez-Barca, Pilar Miralles, Armando Lopez-Guillermo, Eugenia Abella, Miriam Moreno, Juan-Manuel Sancho, Evarist Feliu, Josep-Maria Ribera, Jose-Tomas Navarro
AIDS.2015; 29(7): 811. CrossRef - Non-Hodgkin Lymphomas: Impact of Rituximab on Overall Survival of Patients with Diffuse Large B-Cell and Follicular Lymphoma
José Carlos Jaime-Pérez, Carmen Magdalena Gamboa-Alonso, Alberto Vázquez-Mellado de Larracoechea, Marisol Rodríguez-Martínez, César Homero Gutiérrez-Aguirre, Luis Javier Marfil-Rivera, David Gómez-Almaguer
Archives of Medical Research.2015; 46(6): 454. CrossRef
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Randomized, Multicenter, Phase III Trial of Heptaplatin 1-hour Infusion and 5-Fluorouracil Combination Chemotherapy Comparing with Cisplatin and 5-Fluorouracil Combination Chemotherapy in Patients with Advanced Gastric Cancer
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Kyung Hee Lee, Myung Soo Hyun, Hoon-Kyo Kim, Hyung Min Jin, Jinmo Yang, Hong Suk Song, Young Rok Do, Hun Mo Ryoo, Joo Seop Chung, Dae Young Zang, Ho-Yeong Lim, Jong Youl Jin, Chang Yeol Yim, Hee Sook Park, Jun Suk Kim, Chang Hak Sohn, Soon Nam Lee
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Cancer Res Treat. 2009;41(1):12-18. Published online March 31, 2009
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DOI: https://doi.org/10.4143/crt.2009.41.1.12
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Abstract
PDFPubReaderePub
- Purpose
Heptaplatin (Sunpla) is a cisplatin derivative. A phase IIb trial using heptaplatin resulted in a 34% response rate with mild nephrotoxicity. We conducted a randomized phase III trial of heptaplatin plus 5-FU compared with cisplatin plus 5-FU in patients with advanced gastric cancer. Materials and MethodsOne hundred seventy-four patients (heptaplatin, n=88; cisplatin, n=86) from 13 centers were enrolled. The eligibility criteria were as follows: patients with pathologically-proven adenocarcinoma, chemonaive patients, or patients who had received only single adjuvant chemotherapy, and who had a measurable or evaluable lesion. On day 1, heptaplatin (400 mg/m2) or cisplatin (60 mg/m2) was given over 1 hour with 5-FU (1 gm/m2) on days 1~5 every 4 weeks. ResultsAt the time of survival analysis, the median overall survival was 7.3 months in the 5-FU + heptaplatin (FH) arm and 7.9 months in the 5-FU + cisplatin (FP) arm (p=0.24). Of the FH patients, 34.2% (complete response [CR], 1.3%; partial response [PR], 32.9%) experienced a confirmed objective response compared with 35.9% (CR 0%, PR 35.9%) of FP patients (p=0.78). The median-time-to-progression was 2.5 months in the FH arm and 2.3 months in the FP arm. The incidence of neutropenia was higher with FP (28%) than with FH (16%; p=0.06); grade 3~4 nausea and vomiting were more frequent in the FP than in the FH arm (p=0.01 and p=0.05, respectively). The incidence of increased proteinuria and creatininemia was higher with FH than with FP; however, there was no statistical difference. There were no treatment-related deaths. ConclusionHeptaplatin showed similar effects to cisplatin when combined with 5-FU in advanced gastric cancer patients with tolerable toxicities.
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Citations
Citations to this article as recorded by - Quantum mechanical approaches and molecular docking analysis of platinum metal-based anticancer drugs Lobaplatin and Heptaplatin targeting cancer DNA - a comparative analysis
Madhavi Sahadevan, Mullainathan Sundaram, Karunagaran Subramanian
Chemical Physics Letters.2024; 842: 141191. CrossRef - Cisplatin Resistance in Cancer Therapy: Causes and Overcoming Strategies
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Sakura Iizumi, Atsuo Takashima, Kentaro Sakamaki, Satoshi Morita, Narikazu Boku
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The Efficacy and Safety of Padexol® (Paclitaxel) and Cisplatin for Treating Advanced Non-small Cell Lung Cancer
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Hoon-Kyo Kim, Jun Suk Kim, Hun Mo Ryoo, Dong Gun Shin, Byoung Young Shim, Kyong Hwa Park, Sung Hwa Bae, Chi Hong Kim
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Cancer Res Treat. 2006;38(2):66-71. Published online April 30, 2006
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DOI: https://doi.org/10.4143/crt.2006.38.2.66
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Abstract
PDFPubReaderePub
- Purpose
The authors conducted a multicenter study to evaluate the efficacy and safety of combination chemotherapy with Padexol® and cisplatin for treating patients with advanced non-small cell lung cancer (NSCLC). Materials and MethodsFrom November 2003 to April 2005, 42 chemo-naive patients with advanced NSCLC were enrolled into this study from 4 hospitals. The treatment consisted of Padexol® 175 mg/m2 as a 3-hr infusion, and this was followed by cisplatin 75 mg/m2 administered as an intravenous infusion with standard premedication. The treatment was repeated every 3 weeks. ResultsAmong the 42 patients (pts), 33 pts were evaluable for response. On the per protocol analysis, 1 patient (pt) (3.0%) achieved complete response (CR), 17 pts (51.5%) achieved partial response (PR), 6 pts (18.2%) achieved stable disease (SD), and 9 pts (27.3%) progressed; therefore, the overall response rate was 54.6% (95% CI: 37.6~71.5%). On the intention-to-treat analysis, 1 pt (2.4%) achieved CR, 18 pts (42.9%) achieved PR, 11 pts (26.2%) achieved SD, and 9 pts (21.4%) progressed; therefore, the overall response rate was 45.2% (95% CI: 30.2~60.3%). The response, as evaluated by the investigators, was independently reviewed by 2 external radiologists and it was as follows; 13 PR (43.3%), 14 SD (46.7%) and 3 progressive disease (10%). The median duration of response was 5.9 months. The median follow-up duration was 10.3 months (range: 1.3 to 22.1 months). The median time to progression was 5.8 months (95% CI: 4.7 to 7.4 months). The median survival time on the intention-to-treat analysis was 10.5 months (95% CI: 8.1 to 18.8 months). The most common grade 3 or 4 hematologic toxicities were neutropenia (26/180 cycles, 14.4%), anemia (7/180 cycles, 3.9%) and febrile neutropenia (2/180 cycles, 1.1%). The most frequent grade 3 or 4 non-hematologic toxicities were nausea (14/42 patients, 14.3%), anorexia (3/42 patients, 7.1%) and myalgia (3/42 patients, 7.1%). ConclusionThe authors observed that Padexol® was as good as the other paclitaxel (Taxol® or Genexol®) formulations when combined with cisplatin for treating patients with advanced NSCLC.
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Citations
Citations to this article as recorded by - The role of weekly nanoparticle albumin bound paclitaxel monotherapy as second line or later treatment for advanced NSCLC in China
Puyuan Xing, Yixiang Zhu, Ling Shan, Sipeng Chen, Xuezhi Hao, Junling Li
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Jung Ho Lee, Mi Hye Kwon, Ji Hyun Jeoung, Go Eun Lee, Eu Gene Choi, Moon Jun Na, Hyun Min Cho, Young Jin Kim, Weon Kuu Chung, Young Jun Cho, Ji Woong Son
Journal of Lung Cancer.2007; 6(2): 85. CrossRef
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Effect of Combination Chemotherapy with Docetaxel Plus Cisplatin in Patients with Advanced Non-Small Cell Lung Cancer
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Hee Jung Kang, Min Kyoung Kim, Young Gil Kim, Jae Lyun Lee, Kyung Hee Lee, Myung Soo Hyun, Sung Hwa Bae, Hun Mo Ryoo
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Cancer Res Treat. 2003;35(4):299-303. Published online August 31, 2003
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DOI: https://doi.org/10.4143/crt.2003.35.4.299
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Abstract
PDF
- PURPOSE
This study was conducted to evaluate the efficacy and safety of combination chemotherapy, with docetaxel and cisplatin, as a first line treatment for advanced non-small cell lung cancer.
MATERIALS AND METHODS
Between March 1998 and December 2001, 35 patients with advanced non-small cell lung cancer were enrolled in this study. The patients were treated at 3-week intervals, with one course of a regimen consisting of docetaxel (75 mg/m2 IV for 1 hours) on day 1 and cisplatin (60 mg/m2 IV) on day 2.
RESULTS
The median age of the patients was 60.3 years. Of the 35 patients, 20 and 15 had stage IIIb and stage IV diseases, respectively. A complete response was observed in 1 patient and partial response in 15, with an overall response rate of 46%. The overall median survival duration was 40.3+/-25.2 weeks. The median time to progression and response duration were 21.6+/-5.5 and 15.1+/-5.9 weeks, respectively. The survival duration was statistically significantly longer in the response group (50.6 weeks) than in the non-response group (31.6 weeks) (p<0.05). Of the hematological side effects, grades III and IV leukopenia were observed in 4.8% of patients. Grades III and IV nausea and vomiting were observed in 48.5%, and grades I and II neuropathy in 11.4% of the treated patients. These toxicities were well tolerable and reversible. There were no hypersensitivity reactions.
CONCLUSION
Docetaxel and cisplatin combination chemotherapy is relatively effective and safe in advanced non-small cell lung cancer patients.
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C-erbB-2 Protein Expression and Correlation in Sera and Tumors of Non-Small Cell Lung Cancer Patients
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Hun Mo Ryoo, Sang Yeop Lee, Kyung Hee Lee, Myung Soo Hyun, Mi Jin Kim
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J Korean Cancer Assoc. 2000;32(6):1100-1108.
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Abstract
PDF
- PURPOSE
We have examined the expression of c-erbB-2 oncogene in sera and tissues of non-small cell lung cancer patients.
MATERIALS AND METHODS
Serum levels of c-erbB-2 protein were measured by an enzyme im munoassay in 55 patients with non-small cell lung cancer.
Sera from patients with surgical therapy were evaluated again after surgery. Immunohistochemical staining was performed in 47 of these tumors.
RESULTS
Elevated levels (> or =45 U/mL, control mean 2SD) were observed in 15% of 55 non-small cell lung cancer patients, as compared with none of control subjects (p<0.05). The incidence of elevated level was higher in the adenocarcinoma than squamous cell carcinoma (22% vs 4%, p<0.01). The serum levels of c-erbB-2 protein decreased significantly after surgical tumor ablation (p<0.01). Tissue overexpression was obtained in 23/47 cases (49%). The incidence of c-erbB-2 overexpression was higher in the adenocarcinoma (73% vs 29%, p<0.005). No relationship was found between c-erbB-2 protein expression in serum and tumor tissue and clinicopathologic feature. Elevated serum c-erbB-2 levels predicted tissue overexpression with sensitivity 30% and specificity 96%. There was relationship between serum level and expression in tumor tissue of c-erbB-2 protein.
CONCLUSION
Serum and tissue levels of c-erbB-2 correlate in patients with non-small cell carcinoma. Serum c-erbB-2 protein may be a useful indicator of tumor burden in patients with non-small cell lung cancer.
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