Phase I study of postoperative concurrent chemoradiation with capecitabine as adjuvant treatment for stage II/III operable rectal cancer.
- Author:
Jing JIN
1
;
Ye-Xiong LI
;
Yue-Ping LIU
;
Wei-Hu WANG
;
Tao LI
;
Ning LI
;
Yong-wen SONG
Author Information
- Publication Type:Journal Article
- MeSH: Adolescent; Adult; Aged; Antimetabolites, Antineoplastic; administration & dosage; adverse effects; Capecitabine; Chemotherapy, Adjuvant; Deoxycytidine; administration & dosage; adverse effects; analogs & derivatives; Drug Administration Schedule; Female; Fluorouracil; administration & dosage; adverse effects; analogs & derivatives; Humans; Male; Middle Aged; Neoplasm Staging; Postoperative Care; Radiotherapy, Adjuvant; Radiotherapy, Conformal; Rectal Neoplasms; drug therapy; pathology; radiotherapy; Rectum; surgery
- From: Chinese Journal of Oncology 2006;28(5):393-396
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVEThis phase I study is to determine the maximal tolerated dose and the dose-limiting toxicity of capecitabine combined with standard radiotherapy (RT) as postoperative adjuvant treatment for rectal cancer patients.
METHODSStage II/III rectal cancer patients 18 - 75 years of age had undergone curative surgery with Karnofsky score > or = 70% were eligible to be included in this study. Total dose of RT DT 50 Gy was delivered to the pelvic area in fraction of 2.0 Gy per day for 5 weeks. Capecitabine was orally administered concurrently with radiotherapy for a total of 2 cycles in escalating doses: twice daily at 12 hour interval for consecutive 14 days as one cycle, separated by a seven day rest, then followed by another cycle. From March 2004 to May 2005, 24 patients were included and treated at the following dose levels: daily 1000 mg/m(2) (3 patients), 1200 mg/m(2) (3 patients), 1400 mg/m(2) (3 patients), 1500 mg/m(2) (3 patients), 1600 mg/m(2) (6 patients), and 1700 mg/m(2) (6 patients). Dose-limiting toxicities (DLT) including grade 3 or grade 4 hematologic and nonhematologic toxicity were observed.
RESULTSDose-limiting toxicity was observed in one patient treated at dose of 1600 mg/m(2) with grade 3 diarrhea, and in 2 patients at dose of 1700 mg/m(2) with one grade 3 and one grade 4 diarrhea.
CONCLUSIONDiarrhea is the most common dose-limiting toxicity. In our study, the maximal tolerated dose (MTD) of capecitabine given concurrently with radiotherapy was daily 1600 mg/m(2), from D1 to D14 separated by 7-day rest for 2 cycles. Capecitabine given concurrently with standard radiotherapy is safe and tolerable for operated stage II/III rectal cancer patients.