Oral combination chemotherapy with capecitabine and cyclophosphamide in patients with metastatic breast cancer: phase II study.

Tanaka, Masaki; Tamura, Koichi; Anan, Keisei; Ohno, Satoshi; Nishimura, R; Yamamoto, Yota; Masuda, Norikazu; Mitsuyama, S

doi:10.1158/0008-5472.sabcs-6120

Cited by 4 publications

(13 citation statements)

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“…In the SELECT BC trial, the median time to failure (TTF) was 8.0 months in the group administered S-1 as the rst-line chemotherapy (4). Regarding capecitabine+CPA combination treatment, two phase II studies have already reported this regimen's e cacy (15,16). The ORRs of 35.6% and 30.3% in those studies are consistent with our present study.…”

Section: Discussionsupporting

confidence: 90%

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Phase II study of sequential S-1 and cyclophosphamide therapy in patients with metastatic breast cancer

Yanai

Fujii

Horiguchi

et al. 2020

Preprint

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Background: S-1 and cyclophosphamide (CPA) can be given orally, and their combination may have great potential for treating metastatic breast cancer (MBC). A phase I study of sequential S-1 and CPA therapy was conducted in patients with MBC; the recommended doses that were determined for this regimen were 80 mg/m2/day for S-1 and 100 mg/m2/day for CPA. We then conducted a phase II study of this oral S-1 and CPA regimen. Methods: This was a single-arm, open-label, single-center prospective phase II study to evaluate the efficacy of a sequential S-1 and CPA regimen for MBC. S-1 was administered orally 2´/day for 14 consecutive days, and then CPA was administered orally 2´/day for 14 consecutive days in a repeating 4-week cycle (S-1 for 2 weeks, CPA for 2 weeks). The primary endpoint was the overall response rate (ORR). Secondary endpoints included the overall survival (OS), progression-free survival (PFS), clinical benefit rate (CBR) and safety. Results: Thirty-six patients were enrolled in this study. The overall response was complete response in 0 (0%), partial response in 12 (33.3%), stable disease in 12 (33.3%), and progressive disease in 11 (30.1%) patients. The ORR was 33.3% (12/36). The CBR was 66.7% (24/36). The median PFS was 9.5 months (95%CI: 7.8–12.6 months). The median OS was 20.2 months (95%CI: 15.0–25.4 months) Grade 3/4 adverse events included leukopenia in seven patients (19.4%). Dose reductions because of adverse events occurred in 12 patients (33.3%). There was no treatment-related mortality. Conclusion: The combination of sequential therapy with S-1 and CPA was tolerable and had efficacy with good disease control. Sequential therapy with S-1 and CPA may be a feasible new treatment option for patients with MBC, however, further study is warranted to explore the efficacy of this therapy.Trial registration: JRCT, JRCTs 031180296. Registered 2 December 2019 – Retrospectively registered, https://jrct.hiph.go.jp/latest-detail.jrcts031180296

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Section: Discussionsupporting

confidence: 90%

“…The ORRs of 35.6% and 30.3% in those studies are consistent with our present study. The median PFS in those studies were 6.6 months and 5.2 months, respectively (15,16).…”

Section: Discussionmentioning

confidence: 96%

Phase II study of sequential S-1 and cyclophosphamide therapy in patients with metastatic breast cancer

Yanai

Fujii

Horiguchi

et al. 2020

Preprint

View full text Add to dashboard Cite

show abstract

“…In the SELECT BC trial, the median time to failure (TTF) was 8.0 months in the group administered S-1 as the first-line chemotherapy (4). Regarding capecitabine+CPA combination treatment, two phase II studies have already reported this regimen's efficacy (15,16). The ORRs of 35.6% and 30.3% in those studies are consistent with our present phase II study's values.…”

Section: Discussionsupporting

confidence: 89%

“…The ORRs of 35.6% and 30.3% in those studies are consistent with our present phase II study's values. Those studies' median PFS values were 6.6 months and 5.2 months, respectively (15,16). All-grade leukopenia was observed in 19.4% of our present series, and one patient was unable to continue the therapy.…”

Section: Discussionmentioning

confidence: 48%

“…The use of oral agents can make a significant contribution to a patient's QOL. Several studies reported that oral combination regimens of CPA plus UFT (tegafur/uracil) or capecitabine is effective with well-tolerated toxicities in patients with MBC (15)(16)(17). However, no data evaluating the efficacy of S-1 plus CPA therapy for MBC is available in the existing literature.…”

Section: Introductionmentioning

confidence: 99%

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Phase II study of sequential S-1 and cyclophosphamide therapy in patients with metastatic breast cancer

Yanai

Fujii

Horiguchi

et al. 2020

Preprint

View full text Add to dashboard Cite

Background: S-1 and cyclophosphamide (CPA) can be given orally, and their combination may have great potential for treating metastatic breast cancer (MBC). A phase I study of sequential S-1 and CPA therapy was conducted in patients with MBC; the recommended doses that were determined for this regimen were 80 mg/m 2 /day for S-1 and 100 mg/m 2 /day for CPA. We then conducted a phase II study of this oral S-1 and CPA regimen. Methods:This was a single-arm, open-label, single-center prospective phase II study to evaluate the efficacy of a sequential S-1 and CPA regimen for MBC. S-1 was administered orally 2´/day for 14 consecutive days, and then CPA was administered orally 2´/day for 14 consecutive days in a repeating 4-week cycle (S-1 for 2 weeks, CPA for 2 weeks). The primary endpoint was the overall response rate (ORR). Secondary endpoints included the overall survival (OS), progression-free survival (PFS), clinical benefit rate (CBR) and safety.Results: Thirty-six patients were enrolled in this study. The overall response was complete response in 0 (0%), partial response in 12 (33.3%), stable disease in 12 (33.3%), and progressive disease in 11 (30.1%) patients. The ORR was 33.3% (12/36). The CBR was 66.7% (24/36). The mean PFS was 9.5 months (95%CI: 7.1-11.9 months). The OS was 20.2 months (95%CI: 15.0-25.6 months) Grade 3/4 adverse events included neutropenia in seven patients (19.4%). Dose reductions because of adverse events occurred in 12 patients (33.3%). There was no treatment-related mortality. Conclusion:The combination of sequential therapy with S-1 and CPA was tolerable and had efficacy with good disease control. Sequential therapy with S-1 and CPA is a feasible new treatment option for patients with MBC. T r i a l r e g i s t r a t i o n : J R C T , J R C T s 0 3 1 1 8 0 2 9 6 . R e g i s t e r e d 2 D e c e m b e r 2 0 1 9 -A c k n o w l e d g e m e n t s T h e a u t h o r s w o u l d l i k e t o t h a n k M s . F u m i e T a k a d a a n d M s . H a r u m i K a n a i f o r t h e i r s e c r e t a r i a l a s s i s t a n c e . F T a n References 1 Hortobagyi GN: Treatment of breast cancer. N Engl J Med 14: 974-984, 1998. 2 Suzuki Y, Ogiya R, Oshitanai R, Terao M, Terada M, Morioka T, Tsuda B, Niikura N, Okamura T, Saito Y, Tokuda Y: Feasibility and pharmacokinetics of combined therapy with S-1 and trastuzumab in patients with human epidermal growth factor receptor 2-positive metastatic or recurrent breast cancer. Int

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Fixed dose combination of capecitabine and cyclophosphamide in metastatic breast cancer: Results from THE ENCLOSE phase 2/3 randomized multicenter study

Gupta

Biswas

Babu³

et al. 2021

The Breast

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Aim: To evaluate pharmacokinetics, efficacy and safety of fixed-dose combination (FDC) of oral capecitabine þ cyclophosphamide in metastatic breast cancer (MBC) patients progressing after anthracycline and/or taxane chemotherapy. Methods: In this prospective, adaptive, phase-2/3, open-label study (CTRI/2014/12/005234), patients were randomized (1:1:1) to three FDC doses (doses/day: D1, capecitabine þ cyclophosphamide 1400 mg þ 60 mg; D2, 1800 mg þ 80 mg; D3, 2200 mg þ 100 mg) for 14 days, in 21-day cycles. In Part-I, multiple-dose pharmacokinetics and optimal dose(s) were evaluated with futility analysis. Group(s) with <3 responders based on best overall response rate (BOR, complete response [CR]þpartial response [PR]), were discontinued. Efficacy (BOR, disease control rates [DCR; CR þ PR þ stable disease]) and safety of optimal dose(s) were evaluated in Part-II. Results: Of 66 patients (n ¼ 22/group) in Part-I, pharmacokinetics (D1 ¼ 7/22, D2 ¼ 9/22, D3 ¼ 8/22) showed dose-proportionality for cyclophosphamide and greater than dose-proportionality for capecitabine. Modified intent-to-treat (mITT) analysis showed BOR of 7.14% (1/14) in D1 (discontinued), and 22.22% (4/18) each in D2 and D3, respectively. In Part-II, 50 additional patients were randomized in D2 and D3 (n ¼ 144; total 72 [22 þ 50] patients/group). mITT analysis in D2 (n ¼ 54) and D3 (n ¼ 58) showed BOR of 29.63% (16/54, 95%CI: 17.45e41.81%) and 22.41% (13/58, 95%CI: 11.68e33.15%), respectively. DCR in D2 and D3 were 87.04% (47/54, 95%CI: 78.08e96.00%) and 82.76% (48/58; 95%CI: 73.04e92.48%) after 3 and 57.41% (31/54; 95%CI: 52.41e79.50%) and 50.00% (29/58; 95%CI: 40.40e67.00%), after 6-cycles, respectively. Hand-foot syndrome (16.67%), vomiting (9.72%) in D2, and hand-foot syndrome (18.06%), asthenia (15.28%) in D3 were most-common adverse events.

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Oral combination chemotherapy with capecitabine and cyclophosphamide in patients with metastatic breast cancer: phase II study.

Cited by 4 publications

References 0 publications

Phase II study of sequential S-1 and cyclophosphamide therapy in patients with metastatic breast cancer

Phase II study of sequential S-1 and cyclophosphamide therapy in patients with metastatic breast cancer

Phase II study of sequential S-1 and cyclophosphamide therapy in patients with metastatic breast cancer

Fixed dose combination of capecitabine and cyclophosphamide in metastatic breast cancer: Results from THE ENCLOSE phase 2/3 randomized multicenter study

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