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M. Zwitter
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P3.03 - Poster Session with Presenters Present (ID 473)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Mesothelioma/Thymic Malignancies/Esophageal Cancer/Other Thoracic Malignancies
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.03-030 - Cisplatin with Pemetrexed or Gemcitabine in Prolonged Infusion for Inoperable Mesothelioma: A Phase II Randomized Trial (ID 5853)
14:30 - 14:30 | Author(s): M. Zwitter
- Abstract
Background:
In a single-arm Phase II trial on 78 patients with advanced mesothelioma, promising objective response rate (ORR, 50%) and overall survival (OS, median: 17.0 months) after treatment with cisplatin and low-dose gemcitabine in long infusion (C-GILI) were reported (Kovac et al, Anticancer Drugs 23:230-38, 2012). Here we present a randomized Phase II clinical trial, comparing cisplatin/pemetrexed (CP) and C-GILI.
Methods:
Eligible patients had histologically confirmed malignant mesothelioma, were chemonaive, had performance status (PS) 0-2, adequate organ function to receive cisplatin-based chemotherapy and signed informed consent. Patients were randomized between group A (pemetrexed 500 mg/m2 and cisplatin 75 mg/m2, both on day 1 every 3 weeks) and group B (gemcitabine 250 mg/m2 in 6-hours infusion, d1 and d 8, and cisplatin 75 mg/m2 on d 2, every 3 weeks). The primary endpoint was progression-free survival (PFS); secondary endpoints were ORR, toxicity, quality of life and OS. After progression, cross-over to the alternative regimen was recommended.
Results:
Ninety-six patients entered the trial. Median age was 63 years, 75% were male and 68% had documented exposure to asbestos. Patients were randomized between Group A (CP, 51 pts) and Group B (C-GILI, 45 pts). With ORR over 45%, both regimens were effective. The main Grade 3-4 toxicity was neutropenia: 13.7% for arm A and 33.3% for arm B. Details on demographics, histologic features and effects of treatment are presented in the Table. Median PFS and OS for all patients are 9.4 and 18.6 months, respectively.
Conclusion:
Both arms of primary treatment were effective and well tolerated. Overall survival is among the longest reported so far. This trial confirms the value of C-GILI for treatment of mesothelioma. This treatment may find its indication as second-line treatment, as well as in the first line for deprivileged patients for whom the costs of pemetrexed may be prohibitive.Group A CP, 51 pts Group B C-GILI, 45 pts DEMOGRAPHICS Male/Female 35/16 37/8 Median age 63 64 PS 0-1/PS 2 40/11 36/9 epitheliod/biphasic/ sarcomatoid/unspec 42/2/4/3 32/8/4/2 PRIMARY TREATMENT ORR, % 48.9 50.0 PFS (months, median) 10.6 8.6 % of pts with any grade ≥ 3 toxicity 51.1 55.6 SECOND-LINE TREATMENT AND SURVIVAL % of pts crossing-over to alternative combination 77.8 61.1 OS (months, median) 20.6 18.6
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P3.06 - Poster Session with Presenters Present (ID 492)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Trial Design/Statistics
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.06-006 - Endpoints in Reports on Clinical Trials for Advanced Lung Cancer (ID 4245)
14:30 - 14:30 | Author(s): M. Zwitter
- Abstract
Background:
In reporting experience from clinical trials for advanced lung cancer, proper presentation of endpoints should support decisions for patient management and offer a basis for further research. This postulate was tested in a survey of published trials.
Methods:
The survey includes reports on trials of systemic treatment of advanced lung cancer published between 2013 and 2015 and included in the PubMed database. After excluding reviews, discussion papers, trials on palliative measures, trials on local treatment, case reports and Phase I clinical trials, 316 reports on a total of 303 trials were identified. Analysis focused on primary and secondary endpoints.
Results:
The analysis includes 124 single-arm Phase II trials, 170 randomised Phase II or Phase III trials and 9 Phase IV trials, with a total of 75.467 patients. Only 31 reports dealt with small-cell lung cancer. The main treatment modalities were cytotoxic drugs (100 trials), targeted drugs alone or in combination with chemotherapy (168 trials) or immunotherapy (21 trials). Median interval form closure of recruitment to publication was 35 months and exceeded 4 years in 24.4% of trials. The following weak points of the reports under survey were identified: Objective response rate (ORR) as the primary endpoint (117 reports), and progression-free survival (PFS) as the primary endpoint (125 reports): 41 of these reports did not include information on interval of evaluation and did not specify confirmation of response; in additional 12, this interval exceeded 8 weeks. Overall survival (OS) as the primary endpoint (49 reports): no information on post-trial treatment in 27 reports. Quality of life (QoL) was the primary endpoint only in 6 trials, and was not reported as secondary endpoint in 79.2 % of all trials. Toxicity: 58.4 % of reports provided very fragmented information and offered no data on the proportion of patients with any grade 3 or greater toxicity.
Conclusion:
The quality of research protocols and of reporting the experience from trials on advanced lung cancer are often sub-optimal. Better design of trial protocols, timely precise reporting and meticulous review of papers submitted for publication are strongly encouraged, so as to offer adequate information for clinical practice and for further research. Considering the importance of QoL for any patient with incurable disease, lack of data on QoL is most embarassing. Information on QoL should be a part of every report; this goal is achievable only with simple, easy-to-use instruments such as EQ-5D-5L self-administered questionnaire.
