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J.A. Treat
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MINI 29 - Meta Analyses and Trial Conduct (ID 156)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:D. Morgensztern, M. Redman
- Coordinates: 9/09/2015, 18:30 - 20:00, Mile High Ballroom 2a-3b
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MINI29.08 - Innovation in Non-Small Cell Lung Cancer (NSCLC): Where Are the Clinically Meaningful Outcomes? (ID 1280)
19:10 - 19:15 | Author(s): J.A. Treat
- Abstract
- Presentation
Background:
The American Society of Clinical Oncology (ASCO) recently developed a set of recommended targets for clinically meaningful outcomes to encourage patients, advocates and investigators to expect more of clinical trials in the future and to encourage investigators to design trials and select agents that have the most promise. A systematic literature review was conducted to identify where and how research has successfully met the bar for meaningful improvements in NSCLC patient survival.
Methods:
A systematic search strategy was implemented in MedLine and EMBASE to identify randomized phase III trials reporting overall survival (OS) outcomes from 1974-present. Eligible studies were those that reported OS data in terms of a hazard ratio (HR) or median OS. Patients in the eligible randomized trials were NSCLC patients treated in the first (1L) or post-first line (2L+) setting. Data were extracted related to study population, histology, interventions, and survival from trials of patients with advanced or metastatic disease. All eligibility determinations and extracted data were reviewed by two researchers for accuracy.
Results:
The search strategy identified 2051 articles that were reviewed for eligibility. Of these, 245 were eligible for inclusion. 198 (80.8%) studied 1L, 45 (18.4%) 2L+, and 2 investigated both lines. Of all articles, 51 (20.8%) found significant improvement in survival (Figure 1). Of these, 45 (88.2%) were 1L (41 studies). 14/41 (34.1%) were terminated early or had major protocol changes during study enrollment, and 5/41 (12.2%) reported inconsistent outcomes. In significant 1L studies, the median OS improvement ranged from 0.3-7.0m and HRs ranged from 0.35 to 0.87. The 4 2L+ positive studies, OS improvement ranged from 1.4-2.8m and HRs from 0.70-0.86. Of all 198 1L publications, 12 studies met the significant HR <0.80 bar and an additional 12 studies reported statistically significant gains of ≥2.5m OS. Figure 1. Publications reporting significant improvement in survival Figure 1
Conclusion:
There is a need to improve survival outcomes for patients in NSCLC. In 1L, few studies would have met the ASCO target. Only four 2L+ trials were identified with significant improvements in NSCLC. The results of this systematic literature review inform the interpretation of research and the new bar recommended for meaningful outcomes.
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ORAL 20 - Chemoradiotherapy (ID 124)
- Event: WCLC 2015
- Type: Oral Session
- Track: Treatment of Locoregional Disease – NSCLC
- Presentations: 1
- Moderators:G. Blumenschein, J.Y. Chang
- Coordinates: 9/08/2015, 10:45 - 12:15, 201+203
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ORAL20.02 - Safety Results of the Consolidation Phase of a Phase III (PROCLAIM): Pemetrexed, Cisplatin or Etoposide, Cisplatin plus Thoracic Radiation Therapy followed by Consolidation Cytotoxic Chemotherapy in Locally Advanced Nonsquamous Non-Small Cell Lung Cancer (ID 645)
10:56 - 11:07 | Author(s): J.A. Treat
- Abstract
- Presentation
Background:
Standard treatment for inoperable stage III non-small cell lung cancer (NSCLC) is concurrent chemoradiotherapy. However, many patients die from recurrent disease, indicating that new treatment strategies are needed.
Methods:
PROCLAIM is a phase III trial comparing overall survival in patients with unresectable stage III nonsquamous NSCLC receiving pemetrexed+cisplatin (PemCis) and concurrent radiotherapy for 3 cycles followed by 4 cycles of pemetrexed consolidation (Arm A) versus etoposide+cisplatin (EtoCis) and concurrent radiotherapy for 2 cycles followed by consolidation with a platinum-based doublet of choice for up to 2 cycles (Arm B). Possible consolidation therapies in Arm B were EtoCis, vinorelbine+cisplatin (VinCis), and paclitaxel+carboplatin (PacCarb). Overall efficacy and safety results for the intent-to-treat population will be presented in a separate disclosure. Safety was a secondary objective. Interim safety results for the concurrent phase were previously presented. Here we present safety results for the consolidation phase. Treatment-emergent adverse events (TEAEs) were assessed according to the Common Terminology Criteria for Adverse Events (v3.0, CTCAE). TEAE incidences were compared using Fisher’s exact test (two-sided α=0.05).
Results:
Of 598 randomized patients, 555 were treated in the concurrent phase (Arm A: N=283; Arm B: N=272), most of whom (Arm A: n=229 [80.9%]; Arm B: n=202 [74.3%]) continued on to the consolidation phase (Arm B patients: EtoCis [33.5%], PacCarb [26.8%], VinCis [14.0%]). Baseline characteristics, including age, gender, performance status, smoking status, stage, and origin, were well-balanced across arms. Percentages of patients in Arm A completing ≥2, ≥3, and 4 consolidation cycles were 95.2%, 84.3%, and 73.4%, respectively. Percentages of patients in Arm B completing 2 consolidation cycles (maximum) were EtoCis (89.0%), PacCarb (93.2%), and VinCis (86.8%). Mean dose intensities for pemetrexed, etoposide, vinorelbine, cisplatin, paclitaxel, and carboplatin were 95.4%, 94.0%, 84.2%, 91.2%, 88.7%, and 92.7%, respectively. More patients in Arm B, compared to Arm A, experienced dose reductions, dose omissions, and cycle delays. Patients in Arm B reported more grade 3/4/5 drug-related TEAEs than Arm A (51.0% versus 31.0%, p<0.001; Table). Rates of drug-related serious AEs were similar between groups (Arm A: 14.4%; Arm B: 13.4%).Drug-related Grade 3/4/5 TEAEs Occurring in ≥2% of Patients (or of Clinical Relevance) in the Consolidation Phase
CTCAE Arm A (N=229) n (%) Arm B (N=202) n (%) Neutrophils 27 (11.8) 76 (37.6)* Leukocytes 19 (8.3) 29 (14.4) Hemoglobin 6 (2.6) 9 (4.5) Platelets 5 (2.2) 10 (5.0) Febrile neutropenia 7 (3.1) 7 (3.5) Lymphopenia 8 (3.5) 5 (2.5) Pneumonitis/pulmonary infiltrates 5 (2.2) 2 (1.0) Fatigue 2 (0.9) 4 (2.0) Pneumonia 5 (2.2) 0 Esophagitis 0 3 (1.5) *p<0.001, Fisher’s exact test. Note: Of the TEAEs listed here, only one case (0.4%, Arm A, pneumonia) was grade 5.
Conclusion:
During the PROCLAIM consolidation phase, most patients were able to complete the planned number of cycles in either arm, with the highest dose intensity corresponding to pemetrexed. Pemetrexed consolidation had a significantly lower incidence of drug-related grade 3/4/5 TEAEs than the platinum doublets in Arm B. A more detailed analysis of Arm B (by treatment regimen) is underway.
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P1.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 206)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P1.01-057 - Gemcitabine plus Platinum versus Other Platinum Doublets in Squamous NSCLC (ID 149)
09:30 - 09:30 | Author(s): J.A. Treat
- Abstract
Background:
Squamous cell carcinoma is the second most common histologic subtype of non-small-cell lung cancer (NSCLC). Platinum-based doublet chemotherapy regimens remain the basis of front-line systemic treatment. Most studies in NSCLC included all histologic subtypes. Here we present a pooled analysis of gemcitabine in combination with cisplatin or carboplatin, specifically focusing on patients with squamous NSCLC, from three studies for which individual patient data are available. The objective of this analysis was to evaluate the efficacy of first-line gemcitabine plus platinum (GP) compared with other regimens plus platinum (OP).
Methods:
This analysis included squamous NSCLC patients from three randomized, open-label, phase III studies of gemcitabine: 1) gemcitabine plus cisplatin versus etoposide plus cisplatin (n=61), 2) gemcitabine plus carboplatin versus paclitaxel plus carboplatin (n=128), and 3) gemcitabine plus cisplatin versus pemetrexed plus cisplatin (n=473). Patients were grouped into the GP subgroup (n=324) or the OP subgroup (n=338). Efficacy measures included overall response rate (ORR), overall survival (OS), and time to disease progression (TTP). Stratified (by study) Cox proportional hazard regression models were used to analyze OS and TTP by random assignment factors to identify potential prognostic factors and explore their predictive value.
Results:
Baseline characteristics were similar between the GP and OP groups. Median OS was 9.72 months for GP versus 9.33 months for OP (HR=0.898, p=0.223) (Figure 1). There was a significant difference in median TTP (5.52 months for GP versus 4.73 months for OP; HR=0.792, p=0.008) (Figure 2). ORR was 31.5% for GP, and 27.2% for OP (p=0.229). Cox regression model identified three prognostic factors for OS: Eastern Cooperative Oncology Group performance status, prior radiotherapy, and body mass index. Figure 1. Kaplan–Meier estimates of overall survival Figure 1 Figure 2. Kaplan–Meier estimates of time to disease progressionFigure 2
Conclusion:
This pooled analysis further confirmed the efficacy of gemcitabine plus platinum as first-line treatment of squamous NSCLC.
