Phase II study of S-1 on alternate days plus bevacizumab in patients aged ≥ 75 years with metastatic colorectal cancer (J-SAVER)

Moriwaki, Toshikazu; Sakai, Yoshinori; Ishida, Hiroyasu; Yamamoto, Yoshiyuki; Endo, Shunsuke; Kuramochi, H.; Sato, Mikio; Hatachi, Yukimasa; Bando, Yoshiaki; Mizutani, Takashi; Ikezawa, Kazuto; Shimada, Mitsuo; Amagai, Kenji; Morimoto, Masamitsu; Kobayashi, Kazuma; Tsuji, Akihito; Nishina, Tomohiro; Hyodo, Ichinosuke

doi:10.1007/s10147-019-01465-3

Cited by 7 publications

(5 citation statements)

References 37 publications

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“…The response rate was 44%, and the disease control rate was 88%. S-1 on alternate days combined with bevacizumab showed better tolerability and comparable survival compared with the results of similar studies [15].…”

Section: Discussionmentioning

confidence: 62%

Retrospective Analysis of S-1 plus Bevacizumab as Maintenance Therapy after Induction of S-1 and Oxaliplatin (SOX) plus Bevacizumab as First-Line Chemotherapy in Patients with Metastatic Colorectal Cancer

Uchima¹,

Aomatsu²,

Tsujio³

et al. 2020

JCT

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Background: The SOFT study was a phase III trial designed to validate the non-inferiority of S-1 and oxaliplatin (SOX) plus bevacizumab to mFOLFOX6 plus bevacizumab in terms of PFS in patients with metastatic colorectal cancer (mCRC) who had not previously received chemotherapy. In this study, we retrospectively reviewed cases in which S-1 plus bevacizumab as maintenance therapy after induction of S-1 and Oxaliplatin (SOX) plus bevacizumab as first-line chemotherapy in patients with metastatic colorectal cancer was applied in order to evaluate its efficacy and safety in clinical practice. Material and method: Among the 40 patients with mCRC at the Fuchu Hospital who received SOX plus bevacizumab as a first line treatment between August 2013 and December 2018. The eligible patients had histologically confirmed mCRC. On day 1 of each 3-week period during the study, patients in the SOX plus bevacizumab received a 7.5 mg/kg intravenous infusion of bevacizumab, followed by an intravenous infusion of 130 mg/m 2 oxaliplatin. S-1 (40-60 mg) was administered orally two times per day from after dinner on day 1 to after breakfast on day 15, followed by a 7-day rest. Results: The median PFS was 15.0 months and median OS was 36.0 months. The response rate (RR: complete pus partial response) was 85.0%, and the disease control rate (DCR: RR plus stable disease) was 92.5%. The most common adverse events with SOX plus bevacizumab were hypertension (50%), neurosensory toxicity (50%), anorexia (32.5%), fatigue (45%), pigmentation (39%), Neutrophil count decreased (30%)

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Section: Discussionmentioning

confidence: 62%

Retrospective Analysis of S-1 plus Bevacizumab as Maintenance Therapy after Induction of S-1 and Oxaliplatin (SOX) plus Bevacizumab as First-Line Chemotherapy in Patients with Metastatic Colorectal Cancer

Uchima¹,

Aomatsu²,

Tsujio³

et al. 2020

JCT

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“…An additional 33 studies met the inclusion criteria, but HRs for sidedness were not provided in the article (Results S2). After contacting the corresponding authors of these studies, 7 additional HRs were received 17‐22 . From an additional 8 studies, the HRs could be retrieved from the Kaplan‐Meier curves 23‐28 .…”

Section: Resultsmentioning

confidence: 99%

“…After contacting the corresponding authors of these studies, 7 additional HRs were received. 17 , 18 , 19 , 20 , 21 , 22 From an additional 8 studies, the HRs could be retrieved from the Kaplan‐Meier curves. 23 , 24 , 25 , 26 , 27 , 28 A total of 31 studies were included in the meta‐analysis (Tables S3 and S4 ).…”

Section: Resultsmentioning

confidence: 99%

“… 23 , 24 , 25 , 26 , 27 , 28 A total of 31 studies were included in the meta‐analysis (Tables S3 and S4 ). 14 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 The total number of patients included for the univariable OS analysis was 9558, with 7104 patients in first‐line (22 studies), 1293 in second‐line (3 studies) and 1161 in third‐line or later studies (2 studies). Risk of bias plots is displayed in Figure S5 .…”

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Time‐varying prognostic value of primary tumor sidedness in metastatic colorectal cancer: A population‐based study and meta‐analysis

Kruijssen

Kuil

Vink

et al. 2022

Intl Journal of Cancer

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We studied the prognostic value of primary tumor sidedness in metastatic colorectal cancer over time and across treatment lines. Population data on synchronous metastatic colorectal cancer patients were extracted from the Netherlands Cancer Registry and SEER database. Pubmed, EMBASE and Cochrane library were searched for prospective studies on metastatic colorectal cancer to conduct a meta‐analysis. Inclusion criteria consisted of metastatic disease, systemic treatment with palliative intent and specification of primary tumor location. Data were pooled using a random‐effects model. For the population‐based data, multivariable Cox models were constructed. The Grambsch‐Therneau test was conducted to evaluate the potential time‐varying nature of sidedness. Meta‐regression incorporating treatment‐line as variable was conducted to test the pre‐specified hypothesis that the prognostic value of sidedness varies over time. Analysis of 12 885 and 16 160 synchronous metastatic colorectal cancer patients registered in the Netherlands Cancer Registry and SEER database, respectively, indicated a time‐varying prognostic value of sidedness (P < .01). Thirty‐one studies were selected for the meta‐analysis (9558 patients for overall survival analysis). Pooled univariable hazard ratioleft‐sided/right‐sided for overall survival was 0.71 (95% CI: 0.65‐0.76) in 1st‐line, 0.76 (0.54‐1.06) in 2nd‐line and 1.01 (0.86‐1.19) in 3rd‐line studies. Hazard ratios were significantly influenced by treatment line (P = .035). The prognostic value of sidedness of the primary tumor in metastatic colorectal cancer patients treated with palliative systemic therapy decreases over time since diagnosis, suggesting that sidedness may not be a useful stratification factor in late‐line trials. This decrease in prognostic value should be taken into account when providing prognostic information to patients.

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“…Numerous studies have evaluated the relationship between the administration interval of uoropyrimidine anticancer agents, including S-1, and their antitumor effects and AEs [20][21][22][23][24]. Arai et al performed an alternate-day treatment schedule with S-1 in 36 gastric cancer patients [20].…”

Section: Discussionmentioning

confidence: 99%

Effect of duration of adjuvant chemotherapy with S-1 (6 versus 12 months) for resected pancreatic cancer: the multicenter clinical randomized phase II postoperative adjuvant chemotherapy S-1 (PACS-1) trial

et al. 2023

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Background: Six months of adjuvant chemotherapy with S-1 is standard care for resected pancreatic cancer in Japan; however, the optimal duration has not been established. We aimed to evaluate the impact of duration of adjuvant chemotherapy with S-1.Methods: We performed a multicenter, randomized, open-label, phase II study. Patients with histologically proven invasive pancreatic ductal carcinoma, pathological stage I-III, and no local residual or microscopic residual tumor were eligible. Patients were randomized 1:1 to receive 6 or 12 months of adjuvant chemotherapy with S-1. The primary endpoint was 2-year overall survival (OS). Secondary endpoints were disease-free survival (DFS) and feasibility.Results: A total of 170 patients were randomized (85 per group); the full analysis set was 82 in both groups. Completion rates were 64.7% (6-month group) and 44.0% (12-month group). Two-year OS was 71.5% (6-month group) and 65.4% (12-month group) (hazard ratio (HR): 1.143; 80% con dence interval (CI): 0.841-1.553; P = 0.5758). Two-year DFS was 46.4% (6-month group) and 44.9% (12-month group) (HR: 1.069; 95% CI: 0.727-1.572; P = 0.6448). In patients who completed the regimen, 2-year DFS was 56.5% (6-month group) and 75.0% (12-month group) (HR: 0.586; 95% CI: 0.310-1.105; P = 0.0944).Frequent (≥ 5%) grade ≥ 3 adverse events comprised anorexia (10.5% in the 6-month group) and diarrhea (5.3% vs. 5.1%; 6-vs. 12-month group, respectively).Conclusions: In patients with resected pancreatic cancer, 12 months of adjuvant chemotherapy with S-1 was not superior to 6 months regarding OS and DFS.

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Phase II study of S-1 on alternate days plus bevacizumab in patients aged ≥ 75 years with metastatic colorectal cancer (J-SAVER)

Cited by 7 publications

References 37 publications

Retrospective Analysis of S-1 plus Bevacizumab as Maintenance Therapy after Induction of S-1 and Oxaliplatin (SOX) plus Bevacizumab as First-Line Chemotherapy in Patients with Metastatic Colorectal Cancer

Retrospective Analysis of S-1 plus Bevacizumab as Maintenance Therapy after Induction of S-1 and Oxaliplatin (SOX) plus Bevacizumab as First-Line Chemotherapy in Patients with Metastatic Colorectal Cancer

Time‐varying prognostic value of primary tumor sidedness in metastatic colorectal cancer: A population‐based study and meta‐analysis

Effect of duration of adjuvant chemotherapy with S-1 (6 versus 12 months) for resected pancreatic cancer: the multicenter clinical randomized phase II postoperative adjuvant chemotherapy S-1 (PACS-1) trial

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