Author of

• 12994

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  MO25 - NSCLC - Combined Modality Therapy II (ID 112)

  • Event: WCLC 2013
  • Type: Mini Oral Abstract Session
  • Track: Mesothelioma
  • Presentations: 1
  • Moderators:T. Le Chevalier, K. Pittman
  • Coordinates: 10/30/2013, 10:30 - 12:00, Parkside Ballroom B, Level 1

  • 12997

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    MO25.03 - Safety data from a Phase II study of pemetrexed (PEM) and cisplatin (CIS) with concurrent thoracic radiation after PEM+CIS induction in patients with unresectable locally advanced (LA) Non Squamous Non-Small Cell Lung Cancer (NS-NSCLC) (ID 226)

    10:40 - 10:45  |  Author(s): N. Chouaki
    • Abstract
    • Presentation
    • Slides

    Background
    This single-arm multicenter Phase II study investigated the efficacy and safety of PEM+CIS induction chemotherapy (CT) followed by full-dose PEM+CIS with concurrent radiotherapy (RT) in patients with LA NS-NSCLC. The 1-year progression-free survival (PFS) rate (primary endpoint) was 51.3% (ESMO 2013). Here, we report the safety data for induction CT and concurrent CT+RT.

    Methods
    Patients with unresectable Stage IIIA/IIIB NS-NSCLC (AJCC Version 6), ECOG-PS 0-1 and forced expiratory volume (FEV) >50% of predicted normal FEV received 2 cycles of PEM 500mg/m[2] + CIS 75mg/m[2] on Day 1, every 21 days. Patients who did not progress, with no residual neurological toxicity >Grade (G)2, ECOG-PS 0-1 and lung V20<35% were candidates to receive 2 cycles of the same full-dose PEM+CIS regimen with concurrent thoracic RT of 2Gy/fraction, 5d/week for 7wks (66Gy total). All patients received vitamin supplementation/dexamethasone prophylaxis as per PEM-label.

    Results
    90 patients were enrolled in 4 European countries, 75 (83.3%) completed induction CT and started concurrent CT+RT. Characteristics of 90/75 patients starting induction/concurrent therapy: median age 61/62yrs, male 57%/53%, ECOG-PS 0 66%/65%, mean(SD) FEV 2.3(0.62)/2.3(0.59)L, adenocarcinoma 90%/92%, Stage IIIA 36%/37%. 63 of 75 patients starting concurrent CT+RT (84.0%) received all 4 CT cycles and full dose RT. Median PEM+CIS dose intensities were 90-92% during induction and >97% during concurrent CT+RT, median RT dose was 66Gy (only 6 patients <60Gy). One patient died from study-drug-related toxicity (enteritis) during Cycle 4. Four patients discontinued due to non-fatal drug- or radiation-related adverse events (AEs), 1 on induction CT (renal failure), 3 on concurrent CT+RT (hypoacusis, 2 patients with radiation esophagitis). During induction/concurrent therapy, 8 of 90 patients (8.9%)/12 of 75 patients (16.0%) had ≥1 CT dose delay due to AEs, mainly neutropenia (n=5/6). 2/6 patients (2.2%/8.0%) required CT dose reductions. 13 of 75 patients (17.3%) experienced AEs requiring interruption of radiation, mainly radiation esophagitis (9.3%). Common G1-4 toxicities are presented in the table. 41.3% of patients reported ≥1 G3/4 toxicity during concurrent CT+RT, mainly esophagitis (12.0%), neutropenia (10.7%) and leukopenia (9.3%). G3 mucositis, G3 dysphagia and G3 acute pneumonitis were each reported by 1 patient (1.3%); 6 patients (8.0%) required blood-cell transfusions. Figure 1

    Conclusion
    PEM+CIS induction CT followed by full-dose PEM+CIS with concurrent thoracic RT was well tolerated in this study. Incidences of both G3/4 and low-grade toxicities were low, not only during PEM+CIS induction CT, but also during the subsequent 2 cycles of full-dose PEM+CIS CT with concurrent thoracic RT.

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