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When clinical practice demands to go beyond statistics: Adjuvant chemotherapy of colon cancer. The 3 vs 6 month story

4138 - Efficacy of 3 versus 6 months of oxaliplatin-based adjuvant chemotherapy for Stage III colon cancer (CC): Results from phase III ACHIEVE trial as part of the International Duration Evaluation of Adjuvant therapy (IDEA) Collaboration

Date

11 Sep 2017

Session

When clinical practice demands to go beyond statistics: Adjuvant chemotherapy of colon cancer. The 3 vs 6 month story

Presenters

Takayuki Yoshino

Citation

Annals of Oncology (2017) 28 (suppl_5): v605-v649. 10.1093/annonc/mdx440

Authors

T. Yoshino1, T. Yamanaka2, M. Kotaka3, D. MANAKA4, T. Eto5, J. Hasegawa6, A. Takagane7, M. Nakamura8, T. Kato9, Y. Munemoto10, F. Nakamura11, H. Bando12, H. Taniguchi13, M. Gamoh14, M. Shiozawa15, J. Sakamoto16, S. Saji17, T. Mizushima18, A. Ohtsu1, M. Mori18

Author affiliations

  • 1 Department Of Gastroenterology And Gastrointestinal Oncology, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 2 Department Of Biostatistics, Yokohama City University School of Medicine, 236-0004 - Yokohama/JP
  • 3 Gastrointestinal Cancer Center, Sano Hospital, 655-0031 - Kobe/JP
  • 4 Department Of Surgery, Gastrointestinal Center, Kyoto-Katsura Hospital, 615-8256 - Kyoto/JP
  • 5 Department Of Gastroenterology, Tsuchiura Kyodo General Hospital, 300-0028 - Tsuchiura/JP
  • 6 Department Of Surgery, Osaka Rosai Hospital, 591-8025 - Saki/JP
  • 7 Department Of Surgery, Hakodate Goryoukaku Hospital, Hakodate/JP
  • 8 Aizawa Comprehensive Cancer Center, Aizawa Hospital, 390-8510 - Matsumoto/JP
  • 9 Gastrointestinal Surgery, Kansai Rosai Hospital, 660-8511 - Amagasaki/JP
  • 10 Department Of Surgery, Fukui Saiseikai Hospital, 918-8235 - Fukui/JP
  • 11 Department Of Surgery, Teine Keijinkai Hospital, Sapporo/JP
  • 12 Gastroenterological Surgery, Ishikawa Prefectural Central Hospital, Kanazawa/JP
  • 13 Department Of Surgery, Kyoto Second Red Cross Hospital, Kyoto/JP
  • 14 Medical Oncology, Osaki Citizen Hospital, 989-6183 - Osaki/JP
  • 15 Gastrointestinal Surgery, Kanagawa Cancer Center, Kanagawa/JP
  • 16 Chairperson Of The Institutional Review Board, Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo/JP
  • 17 Chairman, Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo/JP
  • 18 Department Of Surgery, Osaka University Graduate School of Medicine, 565-0871 - Suita/JP
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Abstract 4138

Background

Results of the IDEA project, a prospective preplanned pooled analysis of 6 concurrently conducted randomized phase III trials, were presented at ASCO 2017. ACHIEVE was one of the 6 trials which compared 3 months (3m) duration with 6 months (6m) duration of oxaliplatin-based adjuvant chemotherapy.

Methods

ACHIEVE was an open-label, multicenter trial randomizing patients with stage III colon cancer to receive 3m or 6m of mFOLFOX6/CAPOX after surgery. Choice of regimen was declared before randomization by a site investigator. Primary endpoint was disease-free survival (DFS).

Results

Between August 2012 and June 2014, 1313 patients from Japan were randomized and, of those, 1291 patients were analyzed for analysis. Median age was 66 years; stage distribution was 15% T1-2, 57% T3, and 28% T4 and 26% N2; the highest proportion of patients with CAPOX (75%) among the 6 IDEA trials was included. The frequency of grade 2 or higher neurotoxicity was significantly lower in arm 3m than in arm 6m (14% vs 36%, p 

Conclusions

ACHIEVE was the only investigation in Asia among 6 trials and the results were placed into the context of the IDEA collaboration. Short duration significantly decreased neurotoxicity. It is notable that the efficacy results of overall analysis as well as those of subgroup analyses by risk group and study regimen in ACHIEVE were consistent with the results of IDEA.

Clinical trial identification

UMIN 000008543

Legal entity responsible for the study

Japanese Foundation for Multidisciplinary Treatment of Cancer (JFMC)

Funding

Japanese Foundation for Multidisciplinary Treatment of Cancer (JFMC) under contract with Yakult Honsha

Disclosure

T. Yoshino: Research funding from GlaxoSmithKline K.K. and Boehringer Ingelheim GmbH. T. Yamanaka: Honoraria from Chugai Pharmaceutical and Taiho Pharmaceutical. M. Kotaka: Honoraria from Chugai, Yakult, Merk serono, and Takeda. T. Kato: Honoraria from Chugai Pharmaceutical Co., LTD, Takeda Pharmaceutical Company Limited, Eli Lilly and Company, Bayer Yakuhin, Ltd., Sanofi S.A., and Yakult Honsha Company, Limited. A. Ohtsu: Research funding from BMS. All other authors have declared no conflicts of interest.

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