INTRODUCTION: There is no consensus chemotherapy regimen with concurrent radiotherapy (RT) for inoperable stage IIIA/B non-small-cell lung cancer. This trial evaluated pemetrexed with carboplatin (PCb) or cisplatin (PC) with concurrent RT followed by consolidation pemetrexed. METHODS: In this open-label, noncomparative phase II trial, patients with inoperable stage IIIA/B non-small-cell lung cancer (initially all histologies, later restricted to nonsquamous) were randomized (1:1) to PCb or PC with concurrent RT (64-68 Gy over days 1-45). Consolidation pemetrexed monotherapy was administered every 21 days for three cycles. Primary endpoint was 2-year overall survival (OS) rate. RESULTS:From June 2007 to November 2009, 98 patients were enrolled (PCb: 46; PC: 52). The 2-year OS rate was PCb: 45.4% (95% confidence interval [CI], 29.5-60.0%); PC: 58.4% (95% CI, 42.6-71.3%), and in nonsquamous patients was PCb: 48.0% (95% CI, 29.0-64.8%); PC: 55.8% (95% CI, 38.0-70.3%). Median time to disease progression was PCb: 8.8 months (95% CI, 6.0-12.6 months); PC: 13.1 months (95% CI, 8.3-not evaluable [NE]). Median OS (months) was PCb: 18.7 (95% CI, 12.9-NE); PC: 27.0 (95% CI, 23.2-NE). The objective response rates (ORRs) were PCb: 52.2%; PC: 46.2%. Grade 4 treatment-related toxicities (% PCb/% PC) were: anemia, 0/1.9; neutropenia, 6.5/3.8; thrombocytopenia, 4.3/1.9; and esophagitis, 0/1.9. Most patients completed scheduled chemotherapy and RT during induction and consolidation phases. No drug-related deaths were reported during chemoradiotherapy. CONCLUSIONS: Because of study design, efficacy comparisons cannot be made. However, both combinations with concurrent RT were active and well tolerated.
RCT Entities:
INTRODUCTION: There is no consensus chemotherapy regimen with concurrent radiotherapy (RT) for inoperable stage IIIA/B non-small-cell lung cancer. This trial evaluated pemetrexed with carboplatin (PCb) or cisplatin (PC) with concurrent RT followed by consolidation pemetrexed. METHODS: In this open-label, noncomparative phase II trial, patients with inoperable stage IIIA/B non-small-cell lung cancer (initially all histologies, later restricted to nonsquamous) were randomized (1:1) to PCb or PC with concurrent RT (64-68 Gy over days 1-45). Consolidation pemetrexed monotherapy was administered every 21 days for three cycles. Primary endpoint was 2-year overall survival (OS) rate. RESULTS: From June 2007 to November 2009, 98 patients were enrolled (PCb: 46; PC: 52). The 2-year OS rate was PCb: 45.4% (95% confidence interval [CI], 29.5-60.0%); PC: 58.4% (95% CI, 42.6-71.3%), and in nonsquamous patients was PCb: 48.0% (95% CI, 29.0-64.8%); PC: 55.8% (95% CI, 38.0-70.3%). Median time to disease progression was PCb: 8.8 months (95% CI, 6.0-12.6 months); PC: 13.1 months (95% CI, 8.3-not evaluable [NE]). Median OS (months) was PCb: 18.7 (95% CI, 12.9-NE); PC: 27.0 (95% CI, 23.2-NE). The objective response rates (ORRs) were PCb: 52.2%; PC: 46.2%. Grade 4 treatment-related toxicities (% PCb/% PC) were: anemia, 0/1.9; neutropenia, 6.5/3.8; thrombocytopenia, 4.3/1.9; and esophagitis, 0/1.9. Most patients completed scheduled chemotherapy and RT during induction and consolidation phases. No drug-related deaths were reported during chemoradiotherapy. CONCLUSIONS: Because of study design, efficacy comparisons cannot be made. However, both combinations with concurrent RT were active and well tolerated.
Authors: S I Jalal; H D Riggs; A Melnyk; D Richards; A Agarwala; M Neubauer; R Ansari; R Govindan; D Bruetman; W Fisher; T Breen; C S Johnson; M Yu; L Einhorn; N Hanna Journal: Ann Oncol Date: 2011-12-09 Impact factor: 32.976
Authors: Giorgio Scagliotti; Thomas Brodowicz; Frances A Shepherd; Christoph Zielinski; Johan Vansteenkiste; Christian Manegold; Lorinda Simms; Frank Fossella; Katherine Sugarman; Chandra P Belani Journal: J Thorac Oncol Date: 2011-01 Impact factor: 15.609
Authors: Tudor Ciuleanu; Thomas Brodowicz; Christoph Zielinski; Joo Hang Kim; Maciej Krzakowski; Eckart Laack; Yi-Long Wu; Isabel Bover; Stephen Begbie; Valentina Tzekova; Branka Cucevic; Jose Rodrigues Pereira; Sung Hyun Yang; Jayaprakash Madhavan; Katherine P Sugarman; Patrick Peterson; William J John; Kurt Krejcy; Chandra P Belani Journal: Lancet Date: 2009-09-18 Impact factor: 79.321
Authors: V Surmont; E F Smit; M de Jonge; J G Aerts; K Nackaerts; R Vernhout; J Gras; A Van Wijk; E C J Phernambucq; J P van Meerbeeck; S Senan; C J Kraaij; N Chouaki; J Praag; R J van Klaveren Journal: Lung Cancer Date: 2010-01-22 Impact factor: 5.705
Authors: Kathy S Albain; R Suzanne Swann; Valerie W Rusch; Andrew T Turrisi; Frances A Shepherd; Colum Smith; Yuhchyau Chen; Robert B Livingston; Richard H Feins; David R Gandara; Willard A Fry; Gail Darling; David H Johnson; Mark R Green; Robert C Miller; Joanne Ley; Willliam T Sause; James D Cox Journal: Lancet Date: 2009-07-24 Impact factor: 79.321
Authors: Giorgio Scagliotti; Nasser Hanna; Frank Fossella; Katherine Sugarman; Johannes Blatter; Patrick Peterson; Lorinda Simms; Frances A Shepherd Journal: Oncologist Date: 2009-02-16
Authors: Nasser Hanna; Marcus Neubauer; Constantin Yiannoutsos; Ronald McGarry; James Arseneau; Rafat Ansari; Craig Reynolds; Ramaswamy Govindan; Anton Melnyk; William Fisher; Donald Richards; Daniel Bruetman; Thomas Anderson; Naveed Chowhan; Sreenivasa Nattam; Prasad Mantravadi; Cynthia Johnson; Tim Breen; Angela White; Lawrence Einhorn Journal: J Clin Oncol Date: 2008-11-10 Impact factor: 44.544
Authors: Jons W van Hattum; Ben-Max de Ruiter; Jorg R Oddens; Maarten C C M Hulshof; Theo M de Reijke; Adriaan D Bins Journal: Cancers (Basel) Date: 2021-12-22 Impact factor: 6.639