title: Final results from a Phase II study of pemetrexed and cisplatin with concurrent thoracic radiation after Pem-Cis induction in patients with unresectable locally advanced non-squamous non-small cell lung cancer (NSCLC).
abstract: OBJECTIVE
  This single-arm multicenter Phase II study investigated the efficacy and safety of pemetrexed (Pem) and cisplatin (Cis) induction chemotherapy (CT) followed by full-dose Pem-Cis plus concurrent radiotherapy (RT) in patients with locally advanced non-squamous NSCLC.
  
  
  METHODS
  Patients with unresectable Stage III non-squamous NSCLC received two 21-day cycles of Pem 500 mg/m(2) (vitamin/folic acid supplementation and dexamethasone prophylaxis per Pem-label)+Cis 75 mg/m(2) on Day 1. Eligible patients who had not progressed continued with 2 further cycles of full-dose Pem-Cis plus concurrent RT (2 Gy/fraction, 5 days/week, 66 Gy total). Primary endpoint was the 1-year progression-free survival (PFS) rate.
  
  
  RESULTS
  Of 90 patients enrolled (all treated; median age 61 years, male/female 57%/43%, ECOG performance status 0/1 66%/34%, adenocarcinoma 90%, Stage III 36%/62%), 75 (83%) completed induction CT and started concurrent CT+RT. 64 (71%) patients received all 4 CT cycles and an RT dose ≥60 Gy. The 1-year PFS rate was 51.3% (95%CI: 42.0, 60.5). Median PFS was 10.6 months (95%CI: 8.6, 17.3), median OS was 26.2 months (95%CI: 16.7, not estimable). One patient died from enteritis (treatment-related) during Cycle 4. Four patients discontinued due to treatment-related adverse events, 1 on induction CT (renal failure), 3 on concurrent CT+RT (1 hypoacusis, 2 acute esophagitis). During induction CT, 18.9% of patients reported Grade 3/4 CTCAEs, only neutropenia (2.2%) and syncope (2.2%) were reported by >1 patient. During concurrent CT+RT, 41.3% of patients reported G3/4 CTCAEs, mainly esophagitis (12.0%), neutropenia (10.7%), and leukopenia (9.3%).
  
  
  CONCLUSIONS
  In this study of Pem-Cis induction CT followed by full-dose Pem-Cis with concurrent RT, median PFS was 10.6 months and toxicity was manageable, in line with previous data on Pem-Cis plus RT.
authors.affiliation: Medical Oncology Department, University Hospital Ramon y Cajal, Madrid, Spain. Electronic address: pilargarridol@gmail.com.
authors.forename: Pilar
authors.initials: P
authors.lastname: Garrido
authors.affiliation: Lung Clinic Merheim, Hospital of Cologne, Cologne, Germany.
authors.forename: Walburga
authors.initials: W
authors.lastname: Engel-Riedel
authors.affiliation: Thoracic Oncology Department, Hemer Lung Clinic, Hemer, Germany.
authors.forename: Monika
authors.initials: M
authors.lastname: Serke
authors.affiliation: Department of Oncology Radiotherapy, Paris Descartes University, Georges Pompidou European Hospital, Paris, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Giraud
authors.affiliation: Department of Oncology, Radiation Oncology, University of Turin, Italy.
authors.forename: Umberto
authors.initials: U
authors.lastname: Ricardi
authors.affiliation: Department of Oncology Radiotherapy, University Hospital Ramon y Cajal, Madrid, Spain.
authors.forename: Carmen
authors.initials: C
authors.lastname: Vallejo
authors.affiliation: Medical Oncology Department, Eli Lilly and Company, Houten, The Netherlands.
authors.forename: Carla
authors.initials: C
authors.lastname: Visseren-Grul
authors.affiliation: Clinical Trial Management, Oncology, Lilly S.A. Eli Lilly Benelux N.V., Brussels, Belgium.
authors.forename: Sophie
authors.initials: S
authors.lastname: Ameryckx
authors.affiliation: European Statistics, Oncology, Lilly Deutschland GmbH, Bad Homburg, Germany.
authors.forename: Victoria
authors.initials: V
authors.lastname: Soldatenkova
authors.affiliation: Medical Oncology Department, Eli Lilly and Company, Neuilly-sur-Seine, France.
authors.forename: Nadia
authors.initials: N
authors.lastname: Chouaki
authors.affiliation: Department of Oncology, University of Turin, S. Luigi Hospital, Orbassano (TO), Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Novello
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D059248:Chemoradiotherapy / Q000379:methods; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy / Q000379:methods; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D060828:Induction Chemotherapy / Q000379:methods; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging / Q000379:methods; D000068437:Pemetrexed / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D000068437:Pemetrexed; D002945:Cisplatin
keywords: Cisplatin; Concurrent radiation; Induction chemotherapy; Non-squamous NSCLC; Pemetrexed; Stage III