Leucovorin, fluorouracil, and oxaliplatin plus bevacizumab versus S-1 and oxaliplatin plus bevacizumab in patients with metastatic colorectal cancer (SOFT): an open-label, non-inferiority, randomised phase 3 trial

Yamada, Yasuhide; Takahari, Daisuke; Matsumoto, Hiroshi; Baba, Hideo; Nakamura, Masato; Yoshida, Kazuhiro; Yoshida, Midori; Iwamoto, Shigeyoshi; Shimada, Ken; Komatsu, Yoshito; Sasaki, Yasutsuna; Satoh, Taroh; Takahashi, Keiichi; Mishima, Hideyuki; Muro, Kei; Watanabe, Masahiko; Sakata, Yuh; Morita, Satoshi; Shimada, Yasuhiro; Sugihara, Kenichi

doi:10.1016/s1470-2045(13)70490-x

Cited by 239 publications

(190 citation statements)

References 20 publications

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“…1) While MST has been extended to about two years owing to the progress in chemotherapy, 2,3) complete remission remains di‹cult to achieve. The Guidelines for Colorectal Cancer Treatment 2016 recommends regimens with molecular-targeted drugs such as bevacizumab (Bmab), cetuximab (Cmab), and panitumumab (Pmab) in combination with conventional (‰uorouracil-based) regimens for patients appropriate for intensive therapy.…”

Section: Introductionmentioning

confidence: 99%

Economic Evaluation of mFOLFOX6-based First-line Regimens for Unresectable Advanced or Recurrent Colorectal Cancer Using Clinical Decision Analysis

et al. 2018

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We evaluated four representative chemotherapy regimens for unresectable advanced or recurrent KRAS-wild type colorectal cancer: mFOLFOX6, mFOLFOX6＋bevacizumab (Bmab), cetuximab (Cmab), or panitumumab (Pmab). We employed a decision analysis method in combination with clinical and economic evidence. The health outcomes of the regimens were analyzed on the basis of overall and progression-free survival. The data were drawn from the literature on randomized controlled clinical trials of the above-mentioned drugs. The total costs of the regimens were calculated on the basis of direct costs obtained from the medical records of patients diagnosed with unresectable advanced or recurrent colorectal cancer at Yamagata University Hospital and Yamagata Prefecture Central Hospital. Cost eŠective-ness was analyzed using a Markov chain Monte Carlo (MCMC) method. The study was designed from the viewpoint of public medical care. The MCMC analysis revealed that expected life months and expected cost were 20 months/ 3,527,119 yen for mFOLFOX6, 27 months/8,270,625 yen for mFOLFOX6＋Bmab, 29 months/13,174,6297 yen for mFOLFOX6＋Cmab, and 6 months/12,613,445 yen for mFOLFOX6＋Pmab. Incremental costs per eŠectiveness ratios per life month against mFOLFOX6 were 637,592 yen for mFOLFOX6＋Bmab, 1,075,162 yen for mFOLFOX6＋Cmab, and 587,455 yen for mFOLFOX6＋Pmab. Compared to the conventional mFOLFOX6 regimen, molecular-targeted drug regimens provide better health outcomes, but the cost increases accordingly. mFOLFOX 6＋Pmab is the most costeŠective regimen among those surveyed in this study.

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Section: Introductionmentioning

confidence: 99%

Economic Evaluation of mFOLFOX6-based First-line Regimens for Unresectable Advanced or Recurrent Colorectal Cancer Using Clinical Decision Analysis

et al. 2018

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“…As a first-line chemotherapy, all of the patients underwent combination chemotherapy with oxaliplatin, irinotecan plus 5-fluorouracil/leucovorin, or a prodrug of 5-fluorouracil. All regimens used for the patients in this study were considered to have the same efficacy (18)(19)(20). The distribution of the regimen of chemotherapy was as follows: 5-fluorouracil+ leucovorin+oxaliplatin (FOLFOX), 35; capecitabine+ oxaliplatin (CapeOX), 14; 5-fluorouracil+leucovorin+ irinotecan (FOLFIRI), 7; and received S-1+oxaliplatin (SOX), 1.…”

Section: Resultsmentioning

confidence: 99%

Tumor-infiltrating Lymphocytes Predict the Chemotherapeutic Outcomes in Patients with Stage IV Colorectal Cancer

Shibutani

Maeda

Nagahara

et al. 2018

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Abstract. Background Colorectal cancer (CRC) is one of the most common causes of cancer-related death worldwide (1). About 20-25% of patients with newly diagnosed CRC present with distant metastases (2-4), and only a small population of these patients can undergo curative operation (5). For patients with unresectable metastatic tumors, the standard treatment is systemic chemotherapy. As mentioned in the ESMO clinical practice guidelines (4), an individualized approach to clinical decision-making should be adopted according to the patient's stratification. Therefore, numerous attempts have been made to identify useful prognostic markers for accurate patient stratification.Anticancer immunity is known to affect cancer progression (6). Tumor-infiltrating lymphocytes (TILs), which reflect the immune status of the host (7), have been reported to correlate with the clinical outcome, including the chemotherapeutic outcome in patients with various types of cancer (8-10). However, the method of measuring TILs has differed among previous reports (11)(12)(13)(14)(15). Recently, a new method of measuring TILs in breast cancer was proposed by the International TILs Working Group, using H-E-stained sections (16). In the current study, we applied this method to CRC.The aim of the present study was to evaluate the significance of the TILs in the primary tumor as a marker for predicting the chemotherapeutic outcome in patients with stage IV CRC using the method proposed by the International TILs Working Group. Patients and MethodsPatients. We retrospectively reviewed a database of 57 patients who underwent palliative combination chemotherapy for unresectable metastatic colorectal cancer after resection of the primary tumor at

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“…Randomized studies in Japanese patients have shown that S-1 is as effective as other fluoropyrimidines (5-FU and capecitabine) when given either as monotherapy or in combination with oxaliplatin [11,12] or irinotecan [13]. In the phase 3 'SOFT' study chemo-na€ ıve patients were randomized to mFOLFOX6 plus bevacizumab or SOx plus bevacizumab [12].…”

Section: Discussionmentioning

confidence: 99%

“…In the phase 3 'SOFT' study chemo-na€ ıve patients were randomized to mFOLFOX6 plus bevacizumab or SOx plus bevacizumab [12]. Table 1.…”

Section: Discussionmentioning

confidence: 99%

Experience with S-1 in older Caucasian patients with metastatic colorectal cancer (mCRC): Findings from an observational chart review

et al. 2016

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Background: An aging population will increase the number of older patients with metastatic colorectal cancer (mCRC). However, there is limited knowledge about treatment in older patients as they are under-represented in clinical trials. The oral fluoropyrimidine S-1 is associated with a lower rate of adverse events than capecitabine and may therefore be a suitable drug for elderly. However, data on the use of S-1 in Caucasian mCRC patients are lacking/scarce. Material and methods: In the present study we evaluated safety and the efficacy of S-1 alone or in combination with oxaliplatin (SOx) or irinotecan (IRIS) in older mCRC patients. Patients who received at least one cycle of S-1 (first-line therapy), SOx (mainly first-line therapy) or IRIS (second-line therapy) were included. Results: From June 2012 to December 2014, 71 older patients received 1 cycle of either S-1 (n ¼ 9), SOx (n ¼ 44) or IRIS (n ¼ 18) for mCRC. Median age was 76 years and most patients had a WHO performance status of 0 (32%) or 1 (56%). All patients were evaluable for response and safety. In the SOx group, 18 (41%) and 20 patients (45%) had partial response (PR) and stable disease (SD), respectively (disease control rate 86%). Median progression-free survival (PFS) was 8.5 months and median overall survival (OS) was 18.5 months. In the S-1 group (median age 82 years), PR was 22%, median PFS 6.4 months and median OS 15.8 months. In the IRIS group, PR was 28%, median PFS 7.8 months and the median OS 16.5 months. In general, therapy was well tolerated; main non-hematological toxicities were fatigue and diarrhea. Conclusion: S-1 monotherapy, SOx and IRIS were well tolerated for older patients with mCRC and could become alternative regimens in older mCRC patients. These regimens are now further evaluated in the randomized ongoing NORDIC9 trial.

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Leucovorin, fluorouracil, and oxaliplatin plus bevacizumab versus S-1 and oxaliplatin plus bevacizumab in patients with metastatic colorectal cancer (SOFT): an open-label, non-inferiority, randomised phase 3 trial

Cited by 239 publications

References 20 publications

Economic Evaluation of mFOLFOX6-based First-line Regimens for Unresectable Advanced or Recurrent Colorectal Cancer Using Clinical Decision Analysis

Economic Evaluation of mFOLFOX6-based First-line Regimens for Unresectable Advanced or Recurrent Colorectal Cancer Using Clinical Decision Analysis

Tumor-infiltrating Lymphocytes Predict the Chemotherapeutic Outcomes in Patients with Stage IV Colorectal Cancer

Experience with S-1 in older Caucasian patients with metastatic colorectal cancer (mCRC): Findings from an observational chart review

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