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11.01.2017 | Original Article | Ausgabe 3/2017 Open Access

International Journal of Clinical Oncology 3/2017

Preplanned safety analysis of the JFMC37-0801 trial: a randomized phase III study of six months versus twelve months of capecitabine as adjuvant chemotherapy for stage III colon cancer

Zeitschrift:
International Journal of Clinical Oncology > Ausgabe 3/2017
Autoren:
Takeshi Suto, Megumi Ishiguro, Chikuma Hamada, Katsuyuki Kunieda, Hiroyuki Masuko, Ken Kondo, Hideyuki Ishida, Genichi Nishimura, Kazuaki Sasaki, Takayuki Morita, Shoichi Hazama, Koutarou Maeda, Hideyuki Mishima, Hideyuki Ike, Sotaro Sadahiro, Kenichi Sugihara, Masazumi Okajima, Shigetoyo Saji, Junichi Sakamoto, Naohiro Tomita
Wichtige Hinweise
An erratum to this article is available at http://​dx.​doi.​org/​10.​1007/​s10147-017-1146-6.

Abstract

Background

Six months of adjuvant chemotherapy is regarded as the standard of care for patients with stage III colon cancer. However, whether longer treatment can improve prognosis has not been fully investigated. We conducted a phase III study comparing 6 and 12 months of adjuvant capecitabine chemotherapy for stage III colon cancer, and report here the results of our preplanned safety analysis.

Methods

Patients aged 20–79 years with curatively resected stage III colon cancer were randomly assigned to receive 8 cycles (6 months) or 16 cycles (12 months) of capecitabine (2500 mg/m2/day on days 1–14 of each 21-day cycle). Treatment exposure and adverse events (AEs) were evaluated.

Results

A total of 1304 patients (642 and 636 in the 6-month and 12-month groups, respectively) were analyzed. The most common AE was hand-foot syndrome (HFS). HFS, leukocytopenia, neutropenia, and hyperbilirubinemia (any grade) occurred more frequently in the 12-month group than in the 6-month group. HFS was the only grade ≥3 AE to have a significantly higher incidence in the 12-month group (23 vs 17%, p = 0.011). The completion rate for 8 cycles was 72% in both groups, while that for 16 cycles was 46% in the 12-month group. HFS was the most common AE requiring dose reduction and treatment discontinuation.

Conclusions

Twelve months of adjuvant capecitabine demonstrated a higher cumulative incidence of HFS compared to the standard 6-month treatment period, while toxicities after 12 months of capecitabine were clinically acceptable.

Trial registration

UMIN-CTR, UMIN000001367.

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