Xeloda alone for gastric cancer or for maintenance – pro

5FU has been used in gastric cancer for decades. Xeloda has been found able to subtitute for 5FU in other cancer types. It is now usually used with cisplatin, oxaliplatin or with epirubicin based regimen.

Going back to older studies of Xeloda for gastric cancer, we find that it is effective as a single agent. Phase I studies of capecitabine in various dose and administration regimens were used to test its safety, tolerability and pharmacokinetics. The recommended Phase II dose of capecitabine was set at 2510 mg/m2/day. Other Phase I trials used continuous daily dosing or a 3-weekly intermittent regimen with leucovorin.

The efficacy and safety of 3-week intermittent capecitabine monotherapy was tested in a Korean study that included 44 chemonaive patients. The ORR was 34%, with a median TTP of 3.2 months. While this 3-week inter-mittent schedule has been adopted as the global standard, a 4-week on-and-off schedule has been evaluated in Japan. In these studies, the ORRs were 19.4-26%, the median OS was 8.2-10.0 months and the toxicity profiles were highly favorable. A randomized Phase II study of the 3-week capecitabine regimen was also evaluated in elderly patients; the ORR was 27% with a median TTP of 4.7 months, and the toxicity profile was favorable.

I am not aware of other definitive studies of single agent Xeloda. Uptodate provides a level 2B recommendation for Xeloda in elderly patients with metastatic gastric cancer. NCCN recommends it for adjuvant therapy is stage III patients who did not have D2 resection.

However, NCCN does not cite Xeloda maintenance.

Thereis a recent study of manitenance capecitabine for gastric cancer. In the report by Sun et al, 28 patients with a variety of GI malignancies (at a variety of stages) received continuous, low-dose maintenance capecitabine. Dosing was 1,000 mg twice daily, 7 days a week, but was later revised to 1,000 mg twice daily, Monday through Friday, due to the development of palmar-plantar erythrodysesthesia (PPE) or “hand-foot syndrome” in 67% of patients on the initial schedule. Additional dose reductions occurred for PPE toxicity that did not resolve after the first dose reduction of capecitabine. Generally speaking, this therapy was well tolerated and several patients remained on therapy for extended periods of time.

Sun JF, Wu RR, Norris C, et al. Safety of chronic low-dose capecitabine as maintenance therapy in gastrointestinal cancers. Gastrointest Cancer Res. 2009;3:135–140.

Sakamoto J, Chin K, Kondo K et al.: Phase II study of a 4-week capecitabine regimen in advanced or recurrent gastric cancer. Anticancer Drugs 17(2), 231-236 (2006).

Kang Y, Lee J, Min Y et al.: A randomized multi-center Phase II trial of capecitabine (X) versus S-1 (S) as first-line treatment in elderly patients with metastatic or recurrent unresectable gastric cancer. J. Clin. Oncol. (Meeting Abstracts) 25(Suppl. 18), 4546 (2007).

Koizumi W, Saigenji K, Ujiie S, Terashima M, Sakata Y, Taguchi T: A pilot Phase II study of capecitabine in advanced or recurrent gastric cancer. Oncology 64(3), 232-236 (2003).

Sakamoto J, Chin K, Kondo K et al.: Phase II study of a 4-week capecitabine regimen in advanced or recurrent gastric cancer. Anticancer Drugs 17(2), 231-236 (2006).

Kang Y, Lee J, Min Y et al.: A randomized multi-center Phase II trial of capecitabine (X) versus S-1 (S) as first-line treatment in elderly patients with metastatic or recurrent unresectable gastric cancer. J. Clin. Oncol. (Meeting Abstracts) 25(Suppl. 18), 4546 (2007).

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