PURPOSE: To address whether preoperative chemotherapy plus surgery or surgery plus adjuvant chemotherapy prolongs disease-free survival compared with surgery alone among patients with resectable non-small-cell lung cancer. PATIENTS AND METHODS: In this phase III trial, 624 patients with stage IA (tumor size > 2 cm), IB, II, or T3N1 were randomly assigned to surgery alone (212 patients), three cycles of preoperative paclitaxel-carboplatin followed by surgery (201 patients), or surgery followed by three cycles of adjuvant paclitaxel-carboplatin (211 patients). The primary end point was disease-free survival. RESULTS: In the preoperative arm, 97% of patients started the planned chemotherapy, and radiologic response rate was 53.3%. In the adjuvant arm, 66.2% started the planned chemotherapy. Ninety-four percent of patients underwent surgery; surgical procedures and postoperative mortality were similar across the three arms. Patients in the preoperative arm had a nonsignificant trend toward longer disease-free survival than those assigned to surgery alone (5-year disease-free survival 38.3% v 34.1%; hazard ratio [HR] for progression or death, 0.92; P = .176). Five-year disease-free survival rates were 36.6% in the adjuvant arm versus 34.1% in the surgery arm (HR 0.96; P = .74). CONCLUSION: In early-stage patients, no statistically significant differences in disease-free survival were found with the addition of preoperative or adjuvant chemotherapy to surgery. In this trial, in which the treatment decision was made before surgery, more patients were able to receive preoperative than adjuvant treatment.
RCT Entities:
PURPOSE: To address whether preoperative chemotherapy plus surgery or surgery plus adjuvant chemotherapy prolongs disease-free survival compared with surgery alone among patients with resectable non-small-cell lung cancer. PATIENTS AND METHODS: In this phase III trial, 624 patients with stage IA (tumor size > 2 cm), IB, II, or T3N1 were randomly assigned to surgery alone (212 patients), three cycles of preoperative paclitaxel-carboplatin followed by surgery (201 patients), or surgery followed by three cycles of adjuvant paclitaxel-carboplatin (211 patients). The primary end point was disease-free survival. RESULTS: In the preoperative arm, 97% of patients started the planned chemotherapy, and radiologic response rate was 53.3%. In the adjuvant arm, 66.2% started the planned chemotherapy. Ninety-four percent of patients underwent surgery; surgical procedures and postoperative mortality were similar across the three arms. Patients in the preoperative arm had a nonsignificant trend toward longer disease-free survival than those assigned to surgery alone (5-year disease-free survival 38.3% v 34.1%; hazard ratio [HR] for progression or death, 0.92; P = .176). Five-year disease-free survival rates were 36.6% in the adjuvant arm versus 34.1% in the surgery arm (HR 0.96; P = .74). CONCLUSION: In early-stage patients, no statistically significant differences in disease-free survival were found with the addition of preoperative or adjuvant chemotherapy to surgery. In this trial, in which the treatment decision was made before surgery, more patients were able to receive preoperative than adjuvant treatment.
Authors: Ulas Kumbasar; Hilgardt Raubenheimer; May Al Sahaf; Nizar Asadi; Maria Elena Cufari; Chiara Proli; Periklis Perikleous; Zakiyah Niwaz; Emma Beddow; Vladimir Anikin; Niall McGonigle; Simon Jordan; George Ladas; Michael Dusmet; Eric Lim Journal: J Thorac Dis Date: 2016-01 Impact factor: 2.895
Authors: Matthew J Bott; Stephen C Yang; Bernard J Park; Prasad S Adusumilli; Valerie W Rusch; James M Isbell; Robert J Downey; Julie R Brahmer; Richard Battafarano; Errol Bush; Jamie Chaft; Patrick M Forde; David R Jones; Stephen R Broderick Journal: J Thorac Cardiovasc Surg Date: 2018-12-13 Impact factor: 5.209
Authors: Tina Cascone; Kathryn A Gold; Stephen G Swisher; Diane D Liu; Frank V Fossella; Boris Sepesi; Apar Pataer; Annikka Weissferdt; Neda Kalhor; Ara A Vaporciyan; Wayne L Hofstetter; Ignacio I Wistuba; John V Heymach; Edward S Kim; William N William Journal: Ann Thorac Surg Date: 2017-12-06 Impact factor: 4.330
Authors: Jessica Glover; Frank O Velez-Cubian; Kavian Toosi; Emily Ng; Carla C Moodie; Joseph R Garrett; Jacques P Fontaine; Eric M Toloza Journal: J Thorac Dis Date: 2016-08 Impact factor: 2.895