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Best Timing of Chemo in Rectal CancerUnclear Fluorouracil-Based Adjuvant ChemotherapyAfter Preoperative Chemoradiotherapy in Rectal Cancer: Long-term Results of theEORTC 22921 Randomised Study Bosset JF, Calais, G, Mineur L, et al Lancet Oncol. 2014;15:184-190 Study Summary The investigators provide a long-termfollow-up report of EORTC 22921, which examined the addition of preoperative orpostoperative chemotherapy to preoperative radiation therapy in patients withrectal cancer. There were 2 randomizations. Patients with clinical stage T3 orT4 resectable rectal cancer were randomly assigned to receive radiotherapywithout concomitant chemotherapy (fluorouracil plus leucovorin for 2 cycles,given at weeks 1 and 5 of the radiotherapy) before surgery. After surgery,patients were randomly assigned to surveillance or adjuvant chemotherapy(fluorouracil plus leucovorin for 4 cycles, given every 3 weeks). The primary endpoint was overall survival.Of 1011 patients, 252 were randomly assigned to receive preoperativeradiotherapy and 253 were assigned to each of the other 3 groups. After amedian follow-up of 10.4 years, 10-year overall survival was 49.4% (95% CI,44.6-54.1) for the preoperative radiotherapy group and 50.7% (95% CI,45.9-55.2) for the preoperative chemoradiation group (HR, 0.99; 95% CI,0.83-1.18; P = .91). The 10-year overall survival for the group receivingpostoperative chemotherapy was 51.8% (95% CI, 47.0-56.4) and 48.4% (43.6-53.0)for the surveillance group (HR, 0.91; 95% CI, 0.77-1.09; P = .32). Incidence oflocal relapse at 1 year was 22.4% (95% CI, 17.1-27.6) for those patientsreceiving radiation therapy alone, 11.8% (95% CI, 7.8-15.8) for those receivingpreoperative chemoradiation, 14.5% (95% CI, 10.1-18.9) for those receivingpreoperative radiation and postoperative chemotherapy, and 11.7% (95% CI,7.7-15.6) for those receiving both preoperative and postoperative chemotherapy(P = .0017). There was no significant difference in toxicity profile betweenthe various arms. Viewpoint Current oncologic practice is to recommendboth preoperative and postoperative systemic chemotherapy in patients withlocally advanced rectal cancer. This study underscores the lack of clearbenefit with this approach. Strengths of the study include the large samplesize and long-term follow-up. The study confirms that adding chemotherapyimproves local control, which is of major clinical benefit to patients.However, there was no significant difference in local control rates withchemotherapy given as part of the preoperative regimen (which is currentstandard of care) or as part of the postoperative treatment. Therefore, thereare no clear data supporting postoperative chemotherapy, although we cancontinue to extrapolate from the colon cancer literature.[1,2] Limitations ofthe study include the notable fact that only 43% of patients received full-dosepostoperative treatment; in fact, 25% received none. This speaks to the difficultyof maintaining patients on postoperative therapy, and perhaps the best time toreceive treatment may be upfront in this setting (as in esophageal cancerpatients). Ongoing trials are addressing this approach. |
