Weekday on-weekend off oral capecitabine: a phase I study of a continuous schedule better simulating protracted fluoropyrimidine therapy

Pentheroudakis, George; Pappas, Periklis; Golfinopoulos, Vassilis; Fountzilas, George; Nikolaidou, Martha; Boumba, Vassiliki A.; Vougiouklakis, Theodore; Nikiforidis, L.; Tzamakou, Eleftheria; Siarabi, O.; Marselos, Marios; Pavlidis, Nicholas

doi:10.1007/s00280-007-0419-6

Cited by 8 publications

(5 citation statements)

References 21 publications

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“…The aim of a weekday schedule is to improve tolerability by giving more frequent drug-free intervals, enabling recovery from toxicity. A weekday dosing schedule has shown acceptable tolerability and efficacy similar to the standard schedule in patients with rectal cancer [18,19]. We speculated that by administering paclitaxel for 3 weeks of each 4-week cycle, similar recovery from paclitaxel-related toxicity might be achieved, while providing a regimen more acceptable to patients.…”

Section: Introductionmentioning

confidence: 97%

A GINECO randomized phase II trial of two capecitabine and weekly paclitaxel schedules in metastatic breast cancer

Lortholary

Hardy‐Bessard

Bachelot

et al. 2011

Breast Cancer Res Treat

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To determine whether capecitabine schedule adaptation improves the tolerability of capecitabine-paclitaxel combination therapy for metastatic breast cancer (MBC), patients with anthracycline-pretreated HER2-negative MBC were randomized to either arm A (21-day cycles: capecitabine 1,000 mg/m(2) twice daily, days 1-14; paclitaxel 60 mg/m(2), days 1, 8, and 15) or arm B (28-day cycles: capecitabine 1,000 mg/m(2) twice daily, days 1-5, 8-12, and 15-19; paclitaxel 80 mg/m(2), days 1, 8, and 15). The primary endpoint was the incidence of dose reductions or delays >1 week for grade 3/4 toxicity. Secondary endpoints were efficacy and safety. All 130 randomized patients were evaluable for safety. Dose reduction or delay for grade 3/4 toxicity occurred in 39% of patients in arm A and 34% in arm B during cycles 1-6. In arm A, there were significantly more toxicity-related dose reductions (cycles 1-6: 82 vs. 67%, respectively; P = 0.05) and discontinuations (29 vs. 8%, respectively). Grade 3 diarrhea occurred in 12 and 0%, respectively, and grade 3 hand-foot syndrome in 12 versus 9%, respectively (grade 4 not applicable). There were no detectable differences in efficacy. Weekday capecitabine dosing with weekly paclitaxel may improve tolerability without a detrimental effect on efficacy, and merits further evaluation in patients suited to combination chemotherapy.

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Section: Introductionmentioning

confidence: 97%

A GINECO randomized phase II trial of two capecitabine and weekly paclitaxel schedules in metastatic breast cancer

Lortholary

Hardy‐Bessard

Bachelot

et al. 2011

Breast Cancer Res Treat

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“…The weekdayon/weekend-off schedule is a standard regimen used for preoperative CRT for rectal cancer. Pentheroudakis et al (24) and Ngan et al (25) also reported that the rates of adverse events were lower for the weekday-on/weekend-off schedule compared with those in patients on the continuous schedule. Regarding efficacy, some previous studies reported that the addition of bevacizumab increased the pCR rate.…”

Section: Discussionmentioning

confidence: 94%

Neoadjuvant Radiotherapy with Capecitabine Plus Bevacizumab for Locally Advanced Lower Rectal Cancer: Results of a Single-institute Phase II Study

et al. 2018

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“…and Pentheroudakis et al . also reported that the rates of adverse events were lower for the weekday-on/weekend-off schedule compared with the continuous schedule [26, 30]. In the former report, as a single regimen, the dose level of capecitabine was safely escalated up to 900 mg/m 2 bid combined with 50.4 Gy pelvic irradiation.…”

Section: Discussionmentioning

confidence: 99%

Neoadjuvant capecitabine, bevacizumab and radiotherapy for locally advanced rectal cancer: results of a single-institute Phase I study

Miki

Maeda

Hosono

et al. 2014

Journal of Radiation Research

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The aim of this Phase I clinical trial was to assess the feasibility and safety of capecitabine-based preoperative chemoradiotherapy (CRT) combined with bevacizumab and to determine the optimal capecitabine dose for Japanese patients with locally advanced rectal cancer. Patients with cT3/T4 rectal cancer were eligible. Bevacizumab was administered at 5 mg/kg intravenously on Days 1, 15 and 29. Capecitabine was administered on weekdays concurrently with pelvic radiotherapy at a daily dose of 1.8 Gy, totally to 50.4 Gy. Capecitabine was initiated at 825 mg/m2 twice daily at Dose Level 1, with a planned escalation to 900 mg/m2 twice daily at Dose Level 2. Within 6.1–10.3 (median, 9.4) weeks after the completion of the CRT, surgery was performed. Three patients were enrolled at each dose level. Regarding the CRT-related acute toxicities, all of the adverse events were limited to Grade 1. There was no Grade 2 or greater toxicity. No patient needed attenuation or interruption of bevacizumab, capecitabine or radiation. All of the patients received the scheduled dose of CRT. All of the patients underwent R0 resection. Two (33.3%) of the six patients had a pathological complete response, and five (83.3%) patients experienced downstaging. In total, three patients (50%) developed postoperative complications. One patient developed an intrapelvic abscess and healed with incisional drainage. The other two patients healed following conservative treatment. This regimen was safely performed as preoperative CRT for Japanese patients with locally advanced rectal cancer. The recommended capecitabine dose is 900 mg/m2 twice daily.

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Weekday on-weekend off oral capecitabine: a phase I study of a continuous schedule better simulating protracted fluoropyrimidine therapy

Cited by 8 publications

References 21 publications

A GINECO randomized phase II trial of two capecitabine and weekly paclitaxel schedules in metastatic breast cancer

A GINECO randomized phase II trial of two capecitabine and weekly paclitaxel schedules in metastatic breast cancer

Neoadjuvant Radiotherapy with Capecitabine Plus Bevacizumab for Locally Advanced Lower Rectal Cancer: Results of a Single-institute Phase II Study

Neoadjuvant capecitabine, bevacizumab and radiotherapy for locally advanced rectal cancer: results of a single-institute Phase I study

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