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MO06 - NSCLC - Chemotherapy I (ID 108)
- Event: WCLC 2013
- Type: Mini Oral Abstract Session
- Track: Medical Oncology
- Presentations: 1
- Moderators:R. Perez-Soler, P.M. Ellis
- Coordinates: 10/28/2013, 16:15 - 17:45, Parkside Ballroom A, Level 1
MO06.12 - Efficacy and safety of paclitaxel and carboplatin with bevacizumab for the first-line treatment of patients with nonsquamous non-small cell lung cancer (NSCLC): analyses based on age in the phase 3 PointBreak and E4599 trials (ID 2879)
16:15 - 17:45 | Author(s): S. Hazard
A post hoc analysis of NSCLC patients (pts) aged ≥70 y in the pivotal E4599 trial found increased adverse events (AEs) and numerically decreased overall survival (OS) benefit associated with bevacizumab (BEV) compared with pts <70 y. We evaluated the efficacy and safety of BEV by age in pts in a pooled dataset from the E4599 and PointBreak (PB) trials.
Pts randomized to the PC (paclitaxel and carboplatin ) + BEV arms of E4599 and PB received P 200 mg/m, C AUC 6, and BEV 15 mg/kg q3w for 6 (E4599) or 4 (PB) cycles; Eligible pts received maintenance BEV alone q3w until disease progression or unacceptable toxicity. OS, progression-free survival (PFS), overall response rate (ORR), disease control rate (DCR), and safety were assessed in pts grouped according to age (<65 y, 65–74 y, 70–74 y, <75 y, and ≥75 y). Pt-level data from the PC + BEV arms of E4599 and PB were pooled and compared with data from pts in the PC-alone arm of E4599.
PB and E4599 randomized 467 pts and 434 pts to PC + BEV, respectively, while 444 were randomized to receive PC alone on E4599. Baseline characteristics were balanced between age groups. OS and PFS hazard ratios (HRs) and increases in grade ≥3 AEs for the pooled pt cohort relative to E4599 PC-alone arm are shown (Table). Outcomes were similar in pts <70 y and ≥70 y, and data from the pooled population were similar to those seen in each individual trial (data not shown). ORR for pts <75 y was 39% with PC + BEV vs 26% with PC (P<.01). For pts ≥75 y, ORR was 33% vs 30% (P=.71). DCR in pts <75 y was 70% with PC + BEV vs 53% with PC (P<.01). For pts ≥75 y, DCR was 60% vs 67% (P=.37).
In a pooled exploratory analysis of pt data from E4599 and PB, the statistically significant benefit associated with the addition of BEV to PC appeared consistent across all age groups <75y, while pts ≥75 y receiving PC + BEV had no statistically significant survival benefit. Pts receiving PC + BEV had an increase in grade ≥3 AEs compared with pts receiving PC-alone in all age groups.
[a]Relative to PC-alone arm.
PB + E4599 <65 y n=735 65–74 y n=453 70–74 y n=203 <75 y n=1188 ≥75 y n=157 HR for OS 95% CI P 0.75 0.62–0.89 <.01 0.80 0.64–1.00 .05 0.68 0.48–0.96 .03 0.78 0.68–0.89 <.01 1.05 0.70–1.57 .83 HR for PFS 95% CI P 0.71 0.60–0.85 <.01 0.62 0.49–0.78 <.01 0.68 0.48–0.96 .03 0.69 0.60–0.79 <.01 0.95 0.62–1.44 .80 E4599 n=499 n=277 n=129 n=776 n=102 Δ Grade ≥3 AEs,[a ]% P 13 <.01 21 <.01 23 <.01 15 <.01 25 <.01
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P2.10 - Poster Session 2 - Chemotherapy (ID 207)
- Event: WCLC 2013
- Type: Poster Session
- Track: Medical Oncology
- Presentations: 1
- Coordinates: 10/29/2013, 09:30 - 16:30, Exhibit Hall, Ground Level
P2.10-036 - Overall Survival and Hospitalization Rates in Medicare Patients Diagnosed with Advanced NSCLC Treated With Bevacizumab- Paclitaxel-Carboplatin vs Paclitaxel-Carboplatin: A Retrospective Cohort Study (ID 2419)
09:30 - 16:30 | Author(s): S. Hazard
The study aimed to compare overall survival and hospitalization rates for Medicare patients diagnosed with advanced nonsquamous non-small cell lung cancer (NSCLC) and treated with first-line bevacizumab-carboplatin-paclitaxel (BCP) vs. carboplatin-paclitaxel (CP).
Patients aged ≥65years first diagnosed with nonsquamous NSCLC stage IIIB/ IV between 2006 and 2009 and treated with first-line BCP or CP therapy were identified in the SEER-Medicare database that links cancer registry and Medicare claims data from United States. Outcomes were measured from the treatment initiation date to the end of data availability on 12/31/2010 for hospitalizations and 12/31/2011 for survival. Survival and hospitalization rates are reported from Kaplan-Meier analyses over the follow-up period. Bootstrap methodology was used to test treatment groups differences in median time to death and first hospitalization. Age-stratified survival analyses were conducted using age 75 as a cut point. Inpatient utilization rates are also reported per 100 patient-days for each treatment group and compared in terms of incidence rate ratios (IRR) estimated from negative binomial models adjusted for potential confounders.
Of 1,706 patients, 592 (34.7%) received BCP and 1,114 (65.3%) received CP by inclusion criteria, while 692 (40.6%) were ≥75 years of age. Patient characteristics were balanced between arms for age, sex, disease stage. The BCP group had fewer pre-treatment comorbidities, greater proportion of adenocarcinoma histology, and differences in ethnicity, SEER region, and income compared to the CP group. The median survival time was 10.5 months in the BCP group vs. 8.4 months in the CP group (2.1 months difference, p=0.0007). The difference in median overall survival favoring BCP over CP groups was 1.3 months for patients aged 65-74 years (p=0.11), and 3.3 months for those aged ≥75years (p=0.006). At 6-months and 1 year of follow-up, survival rates for all subjects were, respectively, 70.3% and 43.8% of BCP patients vs. 60.6% and 37.0% of CP patients. After 1 year of follow-up, 69.5% of BCP vs. 75.1% of CP had ≥ 1 hospital admission. Hospitalization rates were significantly lower for BCP patients (adjusted IRRs: 0.82, p=0.003 and 0.77, p=0.002 for hospital admission and hospitalization days). The difference in median time to first hospitalization was 2.1 months (p <.0001). Additional statistics are presented in the Table. Figure 1
In this retrospective analysis of updated SEER-Medicare data, first-line therapy with BCP was associated with longer median survival and reduced hospitalizations compared to CP in patients > 65 years of age.