Cargando…
A Phase III Study to Compare the Efficacy and Safety of Paclitaxel Versus Irinotecan in Patients with Metastatic or Recurrent Gastric Cancer Who Failed in First‐line Therapy (KCSG ST10‐01)
LESSONS LEARNED. Irinotecan could not be proven noninferior to paclitaxel as a second‐line treatment for patients with metastatic or recurrent gastric cancer. The failure to demonstrate noninferiority may have been a result of insufficient patient enrollment. Both agents were tolerable but showed di...
Autores principales: | , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley & Sons, Inc.
2018
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6324622/ https://www.ncbi.nlm.nih.gov/pubmed/30126861 http://dx.doi.org/10.1634/theoncologist.2018-0142 |
_version_ | 1783386006670540800 |
---|---|
author | Lee, Keun‐Wook Maeng, Chi Hoon Kim, Tae‐You Zang, Dae Young Kim, Yeul Hong Hwang, In Gyu Oh, Sang Cheul Chung, Joo Seop Song, Hong Suk Kim, Jin Won Jeong, Su Jin Cho, Jae Yong |
author_facet | Lee, Keun‐Wook Maeng, Chi Hoon Kim, Tae‐You Zang, Dae Young Kim, Yeul Hong Hwang, In Gyu Oh, Sang Cheul Chung, Joo Seop Song, Hong Suk Kim, Jin Won Jeong, Su Jin Cho, Jae Yong |
author_sort | Lee, Keun‐Wook |
collection | PubMed |
description | LESSONS LEARNED. Irinotecan could not be proven noninferior to paclitaxel as a second‐line treatment for patients with metastatic or recurrent gastric cancer. The failure to demonstrate noninferiority may have been a result of insufficient patient enrollment. Both agents were tolerable but showed different toxicity profiles. BACKGROUND. This phase III study compared the efficacy and safety of paclitaxel versus irinotecan in patients with metastatic or recurrent gastric cancer (MRGC) who had experienced disease progression following first‐line chemotherapy. METHODS. Patients were randomized to receive either paclitaxel (70 mg/m(2); days 1, 8, 15, every 4 weeks) or irinotecan (150 mg/m(2) every other week). The primary endpoint was progression‐free survival (PFS). RESULTS. This study was stopped early due to low accrual rate. A total of 112 patients were enrolled; 54 were allocated to paclitaxel and 58 to irinotecan. Median PFS for the paclitaxel and irinotecan groups was 3.5 and 2.1 months, respectively (hazard ratio [HR], 1.27; 95% confidence interval [CI], 0.86–1.88; p = .234). Noninferiority of irinotecan to paclitaxel was not proved because the upper boundary of the 95% CI (1.88) exceeded the predefined upper margin of noninferiority (1.32). Median overall survival (OS) was 8.6 months in the paclitaxel group and 7.0 months in the irinotecan group (HR, 1.39; 95% CI, 0.91–2.11; p = .126). Among toxicities greater than or equal to grade 3, neutropenia (11.5%) was the most common, followed by peripheral neuropathy (7.7%) in the paclitaxel group, and neutropenia (34.5%) followed by nausea, vomiting, and anemia (8.6%, respectively) in the irinotecan group. CONCLUSION. Although paclitaxel showed numerically longer PFS and OS compared with irinotecan, this was statistically insignificant. Both irinotecan and paclitaxel are valid second‐line treatment options in MRGC. |
format | Online Article Text |
id | pubmed-6324622 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | John Wiley & Sons, Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-63246222019-01-18 A Phase III Study to Compare the Efficacy and Safety of Paclitaxel Versus Irinotecan in Patients with Metastatic or Recurrent Gastric Cancer Who Failed in First‐line Therapy (KCSG ST10‐01) Lee, Keun‐Wook Maeng, Chi Hoon Kim, Tae‐You Zang, Dae Young Kim, Yeul Hong Hwang, In Gyu Oh, Sang Cheul Chung, Joo Seop Song, Hong Suk Kim, Jin Won Jeong, Su Jin Cho, Jae Yong Oncologist Clinical Trial Results LESSONS LEARNED. Irinotecan could not be proven noninferior to paclitaxel as a second‐line treatment for patients with metastatic or recurrent gastric cancer. The failure to demonstrate noninferiority may have been a result of insufficient patient enrollment. Both agents were tolerable but showed different toxicity profiles. BACKGROUND. This phase III study compared the efficacy and safety of paclitaxel versus irinotecan in patients with metastatic or recurrent gastric cancer (MRGC) who had experienced disease progression following first‐line chemotherapy. METHODS. Patients were randomized to receive either paclitaxel (70 mg/m(2); days 1, 8, 15, every 4 weeks) or irinotecan (150 mg/m(2) every other week). The primary endpoint was progression‐free survival (PFS). RESULTS. This study was stopped early due to low accrual rate. A total of 112 patients were enrolled; 54 were allocated to paclitaxel and 58 to irinotecan. Median PFS for the paclitaxel and irinotecan groups was 3.5 and 2.1 months, respectively (hazard ratio [HR], 1.27; 95% confidence interval [CI], 0.86–1.88; p = .234). Noninferiority of irinotecan to paclitaxel was not proved because the upper boundary of the 95% CI (1.88) exceeded the predefined upper margin of noninferiority (1.32). Median overall survival (OS) was 8.6 months in the paclitaxel group and 7.0 months in the irinotecan group (HR, 1.39; 95% CI, 0.91–2.11; p = .126). Among toxicities greater than or equal to grade 3, neutropenia (11.5%) was the most common, followed by peripheral neuropathy (7.7%) in the paclitaxel group, and neutropenia (34.5%) followed by nausea, vomiting, and anemia (8.6%, respectively) in the irinotecan group. CONCLUSION. Although paclitaxel showed numerically longer PFS and OS compared with irinotecan, this was statistically insignificant. Both irinotecan and paclitaxel are valid second‐line treatment options in MRGC. John Wiley & Sons, Inc. 2018-08-20 2019-01 /pmc/articles/PMC6324622/ /pubmed/30126861 http://dx.doi.org/10.1634/theoncologist.2018-0142 Text en © AlphaMed Press; the data published online to support this summary is the property of the authors |
spellingShingle | Clinical Trial Results Lee, Keun‐Wook Maeng, Chi Hoon Kim, Tae‐You Zang, Dae Young Kim, Yeul Hong Hwang, In Gyu Oh, Sang Cheul Chung, Joo Seop Song, Hong Suk Kim, Jin Won Jeong, Su Jin Cho, Jae Yong A Phase III Study to Compare the Efficacy and Safety of Paclitaxel Versus Irinotecan in Patients with Metastatic or Recurrent Gastric Cancer Who Failed in First‐line Therapy (KCSG ST10‐01) |
title | A Phase III Study to Compare the Efficacy and Safety of Paclitaxel Versus Irinotecan in Patients with Metastatic or Recurrent Gastric Cancer Who Failed in First‐line Therapy (KCSG ST10‐01) |
title_full | A Phase III Study to Compare the Efficacy and Safety of Paclitaxel Versus Irinotecan in Patients with Metastatic or Recurrent Gastric Cancer Who Failed in First‐line Therapy (KCSG ST10‐01) |
title_fullStr | A Phase III Study to Compare the Efficacy and Safety of Paclitaxel Versus Irinotecan in Patients with Metastatic or Recurrent Gastric Cancer Who Failed in First‐line Therapy (KCSG ST10‐01) |
title_full_unstemmed | A Phase III Study to Compare the Efficacy and Safety of Paclitaxel Versus Irinotecan in Patients with Metastatic or Recurrent Gastric Cancer Who Failed in First‐line Therapy (KCSG ST10‐01) |
title_short | A Phase III Study to Compare the Efficacy and Safety of Paclitaxel Versus Irinotecan in Patients with Metastatic or Recurrent Gastric Cancer Who Failed in First‐line Therapy (KCSG ST10‐01) |
title_sort | phase iii study to compare the efficacy and safety of paclitaxel versus irinotecan in patients with metastatic or recurrent gastric cancer who failed in first‐line therapy (kcsg st10‐01) |
topic | Clinical Trial Results |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6324622/ https://www.ncbi.nlm.nih.gov/pubmed/30126861 http://dx.doi.org/10.1634/theoncologist.2018-0142 |
work_keys_str_mv | AT leekeunwook aphaseiiistudytocomparetheefficacyandsafetyofpaclitaxelversusirinotecaninpatientswithmetastaticorrecurrentgastriccancerwhofailedinfirstlinetherapykcsgst1001 AT maengchihoon aphaseiiistudytocomparetheefficacyandsafetyofpaclitaxelversusirinotecaninpatientswithmetastaticorrecurrentgastriccancerwhofailedinfirstlinetherapykcsgst1001 AT kimtaeyou aphaseiiistudytocomparetheefficacyandsafetyofpaclitaxelversusirinotecaninpatientswithmetastaticorrecurrentgastriccancerwhofailedinfirstlinetherapykcsgst1001 AT zangdaeyoung aphaseiiistudytocomparetheefficacyandsafetyofpaclitaxelversusirinotecaninpatientswithmetastaticorrecurrentgastriccancerwhofailedinfirstlinetherapykcsgst1001 AT kimyeulhong aphaseiiistudytocomparetheefficacyandsafetyofpaclitaxelversusirinotecaninpatientswithmetastaticorrecurrentgastriccancerwhofailedinfirstlinetherapykcsgst1001 AT hwangingyu aphaseiiistudytocomparetheefficacyandsafetyofpaclitaxelversusirinotecaninpatientswithmetastaticorrecurrentgastriccancerwhofailedinfirstlinetherapykcsgst1001 AT ohsangcheul aphaseiiistudytocomparetheefficacyandsafetyofpaclitaxelversusirinotecaninpatientswithmetastaticorrecurrentgastriccancerwhofailedinfirstlinetherapykcsgst1001 AT chungjooseop aphaseiiistudytocomparetheefficacyandsafetyofpaclitaxelversusirinotecaninpatientswithmetastaticorrecurrentgastriccancerwhofailedinfirstlinetherapykcsgst1001 AT songhongsuk aphaseiiistudytocomparetheefficacyandsafetyofpaclitaxelversusirinotecaninpatientswithmetastaticorrecurrentgastriccancerwhofailedinfirstlinetherapykcsgst1001 AT kimjinwon aphaseiiistudytocomparetheefficacyandsafetyofpaclitaxelversusirinotecaninpatientswithmetastaticorrecurrentgastriccancerwhofailedinfirstlinetherapykcsgst1001 AT jeongsujin aphaseiiistudytocomparetheefficacyandsafetyofpaclitaxelversusirinotecaninpatientswithmetastaticorrecurrentgastriccancerwhofailedinfirstlinetherapykcsgst1001 AT chojaeyong aphaseiiistudytocomparetheefficacyandsafetyofpaclitaxelversusirinotecaninpatientswithmetastaticorrecurrentgastriccancerwhofailedinfirstlinetherapykcsgst1001 AT leekeunwook phaseiiistudytocomparetheefficacyandsafetyofpaclitaxelversusirinotecaninpatientswithmetastaticorrecurrentgastriccancerwhofailedinfirstlinetherapykcsgst1001 AT maengchihoon phaseiiistudytocomparetheefficacyandsafetyofpaclitaxelversusirinotecaninpatientswithmetastaticorrecurrentgastriccancerwhofailedinfirstlinetherapykcsgst1001 AT kimtaeyou phaseiiistudytocomparetheefficacyandsafetyofpaclitaxelversusirinotecaninpatientswithmetastaticorrecurrentgastriccancerwhofailedinfirstlinetherapykcsgst1001 AT zangdaeyoung phaseiiistudytocomparetheefficacyandsafetyofpaclitaxelversusirinotecaninpatientswithmetastaticorrecurrentgastriccancerwhofailedinfirstlinetherapykcsgst1001 AT kimyeulhong phaseiiistudytocomparetheefficacyandsafetyofpaclitaxelversusirinotecaninpatientswithmetastaticorrecurrentgastriccancerwhofailedinfirstlinetherapykcsgst1001 AT hwangingyu phaseiiistudytocomparetheefficacyandsafetyofpaclitaxelversusirinotecaninpatientswithmetastaticorrecurrentgastriccancerwhofailedinfirstlinetherapykcsgst1001 AT ohsangcheul phaseiiistudytocomparetheefficacyandsafetyofpaclitaxelversusirinotecaninpatientswithmetastaticorrecurrentgastriccancerwhofailedinfirstlinetherapykcsgst1001 AT chungjooseop phaseiiistudytocomparetheefficacyandsafetyofpaclitaxelversusirinotecaninpatientswithmetastaticorrecurrentgastriccancerwhofailedinfirstlinetherapykcsgst1001 AT songhongsuk phaseiiistudytocomparetheefficacyandsafetyofpaclitaxelversusirinotecaninpatientswithmetastaticorrecurrentgastriccancerwhofailedinfirstlinetherapykcsgst1001 AT kimjinwon phaseiiistudytocomparetheefficacyandsafetyofpaclitaxelversusirinotecaninpatientswithmetastaticorrecurrentgastriccancerwhofailedinfirstlinetherapykcsgst1001 AT jeongsujin phaseiiistudytocomparetheefficacyandsafetyofpaclitaxelversusirinotecaninpatientswithmetastaticorrecurrentgastriccancerwhofailedinfirstlinetherapykcsgst1001 AT chojaeyong phaseiiistudytocomparetheefficacyandsafetyofpaclitaxelversusirinotecaninpatientswithmetastaticorrecurrentgastriccancerwhofailedinfirstlinetherapykcsgst1001 |