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S. Ameryckx
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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
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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): S. Ameryckx
- Abstract
- Presentation
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 1Conclusion
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.Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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P2.10 - Poster Session 2 - Chemotherapy (ID 207)
- Event: WCLC 2013
- Type: Poster Session
- Track: Medical Oncology
- Presentations: 1
- Moderators:
- Coordinates: 10/29/2013, 09:30 - 16:30, Exhibit Hall, Ground Level
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P2.10-004 - Addition of bevacuzimab (BEV) to pemetrexed (PEM) plus cisplatin (CIS) induction and PEM maintenance therapy in 1st line setting for treatment of advanced nonsquamous non small cell lung cancer (NS-NSCLC) - final results and safety update from a phase 2 study (ID 234)
09:30 - 09:30 | Author(s): S. Ameryckx
- Abstract
Background
1st line PEM+CIS induction chemotherapy (CT) followed by PEM maintenance and 1st line BEV-based CT followed by BEV maintenance offer clinical benefit (progression-free and overall survival; PFS and OS) in NS-NSCLC. This study explored efficacy and safety of 1st line induction PEM+CIS+BEV followed by maintenance PEM+BEV.Methods
Patients with advanced NS-NSCLC and ECOG performance status (PS) 0-1 were planned to receive 4 cycles PEM 500 mg/m[2], CIS 75 mg/m[2], BEV 7.5 mg/kg, given every 3 weeks. In the absence of progressive disease (PD) and in the case of ECOG PS 0-1, patients could continue on PEM+BEV until PD or unacceptable toxicity. All patients received vitamin supplementation as per PEM label. Primary endpoint was PFS; secondary endpoints included OS, response rate and toxicity. PFS without Grade (G)4 toxicity was additionally assessed.Results
109 patients were enrolled in 5 countries. Characteristics: median age 61 years, males/females 59/41%, ECOG PS 0/1 54/46%, stage IIIB/IV 9/91%, adenocarcinoma 91%. 72 patients (66%) received maintenance CT. Overall median (maximum) number of cycles were 8(34) for PEM+BEV and 4(4) for CIS. Median PFS was 6.9 months (90% CI 5.7, 8.3). Table 1 summarizes efficacy data; Table 2 presents G1-4 adverse event (AE) data, including AEs of special interest regarding BEV. 2 patients died from study-drug related toxicity (GI hemorrhage, pneumonia aspiration; during induction CT). Figure 1 Figure 2Conclusion
In this study of PEM+CIS+BEV induction CT followed by PEM+BEV maintenance, median PFS was 6.9 months. The addition of BEV to PEM-CIS induction and PEM maintenance was associated with acceptable and expected toxicities. Main G3/4 toxicities included neutropenia and fatigue, hypertension was less common.
