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Clinical Trial
. 2020 Jan;25(1):118-125.
doi: 10.1007/s10147-019-01546-3. Epub 2019 Sep 21.

Phase II study of capecitabine plus oxaliplatin (CapOX) as adjuvant chemotherapy for locally advanced rectal cancer (CORONA II)

Norifumi Hattori  1 , Goro Nakayama  2 , Keisuke Uehara  3 , Toshisada Aiba  3 , Kiyoshi Ishigure  4 , Eiji Sakamoto  5 , Yuichiro Tojima  6 , Mitsuro Kanda  2 , Daisuke Kobayashi  2 , Chie Tanaka  2 , Suguru Yamada  2 , Masahiko Koike  2 , Michitaka Fujiwara  2 , Masato Nagino  3 , Yasuhiro Kodera  2
Affiliations
Clinical Trial

Phase II study of capecitabine plus oxaliplatin (CapOX) as adjuvant chemotherapy for locally advanced rectal cancer (CORONA II)

Norifumi Hattori et al. Int J Clin Oncol. 2020 Jan.

Abstract

Objective: This multicenter, single-arm phase II study (UMIN000008429) aimed to evaluate the efficacy and safety of capecitabine plus oxaliplatin (CapOX) as postoperative adjuvant chemotherapy for patients with locally advanced rectal cancer.

Methods: Patients with resectable clinical Stage II or III rectal cancer were enrolled to receive eight cycles of CapOX therapy (130 mg/m2 oxaliplatin on day 1 and 2000 mg/m2 oral capecitabine on days 1-14, every 3 weeks) after curative surgical resection. The primary endpoint was 3-year relapse-free survival (RFS) rate, and secondary endpoints were 3-year overall survival (OS) rate, treatment compliance, and safety.

Results: A total of 40 patients (Stage II, 21; Stage III, 19) were enrolled between September 2012 and November 2015 from seven institutions. Thirty-nine patients (97%) received R0 resection, and 32 patients (84%) received postoperative CapOX therapy. The completion rate of all eight cycles of CapOX therapy was 66%. Relative dose intensities were 87% for oxaliplatin and 84% for capecitabine. At a median follow-up period of 46 months, disease recurrence was observed in nine patients, including three with local recurrence. Three-year RFS and OS rates were 75% (95% CI 57-86%) and 96% (95% CI 80-99%), respectively. Frequencies of Grade ≥ 3 hematological and non-hematologic adverse events were 19% and 38%, respectively.

Conclusion: CapOX therapy is feasible as adjuvant chemotherapy for locally advanced rectal cancer.

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Conflict of interest statement

The authors report no conflicts of interest.

Figures

Fig. 1
Fig. 1
Consort diagram. A total of 40 patients enrolled between September 2012 and November 2015 underwent surgical resection. CapOX adjuvant chemotherapy was administered to 32 patients. N total number of patients, n number of patients, CapOX capecitabine and oxaliplatin
Fig. 2
Fig. 2
Survival outcomes (ITT population). a Three-year RFS rate was 80% (95% CI 64–89%). b Three-year OS rate was 97% (95% CI 83–99%). RFS relapse-free survival, OS overall survival, N total number of patients
Fig. 3
Fig. 3
Survival outcomes (per protocol population). a Three-year RFS rate was 75% (95% CI 57–86%). b Three-year OS rate was 96% (95% CI 80–99%). c Three-year cumulative rate of local recurrence and distant recurrence were 9.3% (95% CI 3.0–25%) and 21% (95% CI 10–39%), respectively. RFS relapse-free survival, OS overall survival, N total number of patients
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