NEW YORK (Reuters Health) Dec 15 - Treatment of early-stage non-small-cell lung cancer (NSCLC) with cisplatin and vinorelbine after complete tumor resection significantly improves 5-year survival, a recent study has found.
The results reflect what the authors say is the longest follow-up of any recent trial of adjuvant therapy in NSCLC. The report, by Dr. Charles A. Butts of the Cross Cancer Institute, Edmonton, Alberta and colleagues, was published online November 23 by the Journal of Clinical Oncology.
After complete resection, 482 NSCLC patients with stage IB or II cancers were randomized to adjuvant therapy or observation only. They were followed for a median of 9.3 years (range, 3.2 to 13.4). Thirty-three patients were lost to follow-up and 271 died - 143 in the observation group and 128 in the chemotherapy group.
The 5-year survival rate for was 67% with adjuvant chemotherapy and 56% in the control group. Median survival times were 3.6 years with observation versus 6.8 years with treatment.
Whereas stage II patients had had significantly improved survival with chemotherapy (hazard ratio, 0.68), treatment afforded no overall survival benefit in stage IB disease.
A "clinically meaningful benefit" of adjuvant treatment for stage IB patients did become evident when subgroups were analyzed, however. For instance, stage IB patients with tumors 4 cm or larger had 5-year survival rates of 79% with chemotherapy, versus 59% with observation. Patients with tumors smaller than 4 cm had no clinical benefit from the treatment, however.
Adjuvant chemotherapy was not associated with an increase in death from other causes, and there was no evidence of unexpected late toxicity or of any increase in second malignancies, the researchers said.
The study is an updated survival analysis of the JBR.10 trial, a phase III randomized trial in which no postoperative radiation was permitted.
Both this report and an accompanying editorial note that the finding of a long-term benefit from the adjuvant regimen is at odds with most other recent studies of adjuvant chemotherapy in NSCLC.
This cisplatin-plus-vinorelbine combination "has been the only regimen that has shown a consistent result in terms of improvement in survival in the adjuvant setting," Dr. Butts told Reuters Health by e-mail.
In the editorial, Dr. Jean-Yves Douillard of the Centre Rene Gauducheau, St. Herblain, France, suggests that based on this and other recent studies, the choice of both the platinum-based agent and the drug to combine with it could be crucial.
In light of current evidence, Dr. Douillard writes, "cisplatin and vinorelbine should be the recommended regimen for a durable and reproducible benefit" in the types of NSCLC covered in the present study.
J Clin Oncol 2009.
Δεν υπάρχουν σχόλια:
Δημοσίευση σχολίου