Journal of clinical oncology : official journal of the American Society of Clinical Oncology 2010-01-01
Randomized phase III trial of vinorelbine plus cisplatin compared with observation in completely resected stage IB and II non-small-cell lung cancer: updated survival analysis of JBR-10.
Abstract
PURPOSE Adjuvant cisplatin-based chemotherapy (ACT) is now an accepted standard for completely resected stage II and III A non-small-cell lung cancer (NSCLC). Long-term follow-up is important to document persistent benefit and late toxicity. We report here updated overall survival (OS) and disease-specific survival (DSS) data. PATIENTS AND METHODS Patients with completely resected stage IB (T2N0, n = 219) or II (T1-2N1, n = 263) NSCLC were randomly assigned to receive 4 cycles of vinorelbine/cisplatin or observation. All efficacy analyses were performed on an intention-to-treat basis. Results Median follow-up was 9.3 years (range, 5.8 to 13.8; 33 lost to follow-up); there were 271 deaths in 482 randomly assigned patients. ACT continues to show a benefit (hazard ratio [HR], 0.78; 95% CI, 0.61 to 0.99; P = .04). There was a trend for interaction with disease stage (P = .09; HR for stage II, 0.68; 95% CI, 0.5 to 0.92; P = .01; stage IB, HR, 1.03; 95% CI, 0.7 to 1.52; P = .87). ACT resulted in significantly prolonged DSS (HR, 0.73; 95% CI, 0.55 to 0.97; P = .03). Observation was associated with significantly higher risk of death from lung cancer (P = .02), with no difference in rates of death from other causes or second primary malignancies between the arms. CONCLUSION Prolonged follow-up of patients from the JBR.10 trial continues to show a benefit in survival for adjuvant chemotherapy. This benefit appears to be confined to N1 patients. There was no increase in death from other causes in the chemotherapy arm.
Related Questions
Would you offer adjuvant therapy for patients with resected NSCLC <3 cm with visceral pleural involvement and no lymph node involvement?
The short answer is "no", I do not typically recommend adjuvant systemic therapy or radiotherapy for people with completely resected, small (<3 cm) T2aN0M0, stage IIA NSCLC.The NCCN guidelines state that "adjuvant chemotherapy is recommended for high-risk features" in people with resected stage IB o...
How can you adjust neoadjuvant or adjuvant platinum based chemotherapy for stage Stage II-III non-small cell lung cancer in patients with significant renal insufficiency?
This is a great question as to one of our key responsibilities as practicing oncologists. Properly tailoring treatment - in this example chemotherapy to our patient’s needs – recognizing particular co-morbidities of concern, his/her willingness to tolerate side effects, and striking the right balanc...
What high risk features for stage IB NSCLC would lead you to consider adjuvant chemotherapy?
Short answer is "no", I would not change practice based on the recently presented (ASCO) a non-randomized analysis of the potential benefits of adjuvant chemotherapy for patients with stage I NSCLC in Japan (Tsutani, et al. JCO 37(15S):457s, 2019; abst 8500). Many of these patients received UFT rath...