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E. Pichon
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MINI 25 - Trials, Radiation and Other (ID 142)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Thymoma, Mesothelioma and Other Thoracic Malignancies
- Presentations: 1
- Moderators:J.M. Clavero, R. Hassan
- Coordinates: 9/08/2015, 16:45 - 18:15, 702+704+706
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MINI25.08 - Systemic Treatment in Advanced Thymic Epithelial Tumors. Insights From a Prospective Cohort of 888 Patients Enrolled in RYTHMIC (ID 1166)
16:45 - 18:15 | Author(s): E. Pichon
- Abstract
Background:
RYTHMIC (Réseau tumeurs THYMiques et Cancer) is the French nationwide network for thymic malignancies. Starting 2012, all patients diagnosed with thymic tumor had to be enrolled, as recommended by the French National Cancer Institute, part of good clinical practice.
Methods:
RYTHMIC prospective database is hosted by the French Thoracic Cancer Intergroup (IFCT), and collects clinical, imaging, treatment, and follow-up data of patients discussed at the reference national multidisciplinary tumor board (MTB). Data cutoff was April 1[st], 2015 for this analysis.
Results:
1089 questions were raised at the MTB about the management of 888 patients with thymic epithelial tumor. Among assessable cases, Masaoka-Koga stage III-IV tumors accounted for 42% of cases; histology was thymoma in 82% of cases, and thymic carcinoma in 18% of cases. First-line treatment of locally advanced disease, and management (diagnosis and treatment) of recurrent disease led to raise 227 (21%), and 234 (21%) questions at the MTB, respectively, 312 (68%) of which were about the modalities of systemic treatment. Figure 2 shows the proposed regimens for primary (A) and exclusive (B) chemotherapy in treatment-naïve patients, and chemotherapy (C) and targeted agents (D) for recurrent tumors. Combination of cisplatin, adriamycin, and cyclophosphamide and carboplatine, paclitaxel were the most frequently proposed regimens as first- and second-line treatment, respectively. Figure 1 Figure 2
Conclusion:
RYTHMIC is an exhaustive registry of thymic malignancies, which provides unique insights in the management of advanced and recurrent tumors with systemic agents. Meanwhile, limited data have been made available in the literature so far, as clinical trials were conducted in small numbers of patients, and existing databases enrolled a majority of surgically resected, early-stage tumors. Through the use of targeted agents, RYTHMIC allows the rapid implementation of new results in clinical practice, while ensuring patients an equal access to therapeutic innovation. Supported by Institut National du Cancer
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P2.08 - Poster Session/ Thymoma, Mesothelioma and Other Thoracic Malignancies (ID 225)
- Event: WCLC 2015
- Type: Poster
- Track: Thymoma, Mesothelioma and Other Thoracic Malignancies
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.08-030 - Sunitinib in Patients with Advanced Thymoma and Thymic Carcinoma. Retrospective Analysis from RYTHMIC Database (ID 1160)
09:30 - 17:00 | Author(s): E. Pichon
- Abstract
Background:
Sunitinib is a potent oral tyrosine kinase inhibitor of VEGFR, KIT and PDGFR. In a single arm phase 2 study of sunitinib after at least one previous line of chemotherapy, a 26% of partial response rate (PR) was reported in thymic carcinoma (TC) and 6% in thymoma (T), with a median progression free survival (mPFS) of 7.2 months and 8.5 months, respectively. We investigated if off-labelled prescription of sunitinib in this population induced the same efficacy signal.
Methods:
We investigated the database of the French thymic malignancies network. We reviewed advanced T and TC patients (p) who were treated with sunitinib in order to evaluate patient’s outcome.
Results:
From October 2011 to January 2015, 28 patients of 7 institutions were identified (20 TC and 8 T). 32% of patients were females and median age was 49.7 y. Fifteen patients (54%) received sunitinib in ≥ 4[th] line of treatment. Two patients received sunitinib in 1[st] line treatment (1 T and 1 TC). The 37.5 mg was the initial dose of sunitinib in 16p. In the whole population, the PR rate was 21% (of 20p with TC, 4 (20%) had a PR; and of 8p with T, 2 (25%) had partial responses). Of note, PR to sunitinib was independent of treatment line (1p at 1[st] lines, 1p at 3[rd] line, 2 p at 4[th] line and 2p at ≥ 5[th] line). 3 TC p were c-KIT positive, without a clear relationship with response rate (1 PR, 2 PD). The mPFS in whole population was 103 days. For TC the mPFS was 87 days and 139 days for T. Sunitinib adverse events were manageable and tolerable. 8p stopped sunitinib due to toxicity. The median overall survival (OS) in the whole population was 175 days, with prolonged OS in T vs. TC (403 days vs. 166 days)
Conclusion:
Sunitinib is an active treatment in thymic epithelial malignancies irrespective of histological subtype, even in a heavy pre-treated population, and treatment line, supporting antiangiogenic therapies as an alternative treatment option for these patients.
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P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.01-081 - Navotrial 3: Oral Vinorelbine + Cisplatin (P) vs Gemcitabine + P in 1st Line Advanced Squamous Non-Small-Cell Lung Cancer (ID 1210)
09:30 - 17:00 | Author(s): E. Pichon
- Abstract
Background:
Gemcitabine – cisplatin is one of the most frequent treatment used in patients with advanced S-NSCLC without any direct comparison with other active doublets and with superiority reported only versus pemetrexed-cisplatin (Scagliotti G., 2008). Oral vinorelbine-cisplatin is also one main standard doublet but no trial has been specifically conducted in S-NSCLC. The aim of the current study is to assess efficacy and safety of oral vinorelbine-cisplatin and gemcitabine-cisplatin in S-NSCLC patients (NAVoTRIAL 3).
Methods:
This is a phase II, international multicentre, randomised study (1:1). At baseline, patients must have stage IIIB or IV, squamous histologically or cytologically proven NSCLC, Karnofsky PS ≥70 and must not have received prior systemic CT or immunotherapy for NSCLC.Patients in arm A will receive oral vinorelbine at the dose of 60 mg/m² in combination with cisplatin at the dose of 80 mg/m² on day 1, followed by oral vinorelbine, 60 mg/m² on day 8 at the first cycle; the dose is increased at the second cycle to 80 mg/m² in absence of haematological tolerance. Both agents are repeated every 3 weeks, followed by maintenance after four cycles for patients with OR/SD: oral vinorelbine at the same dose as cycle 4, day 1, 8 every 3 weeks.Patients in arm B will receive gemcitabine at the dose of 1250 mg/m² in combination with cisplatin 75 mg/m² on day 1, followed by gemcitabine, 1250 mg/m² on day 8. Both agents are repeated every 3 weeks, followed by maintenance after four cycles for patients with OR/SD : Gemcitabine at the same dose as cycle 4, day 1, 8 every 3 weeks. The primary endpoint is the disease control rate (NC, CR, PR, RECIST 1.1). Enrolment began in March 2013 and 110 patients will be recruited.
Results:
Not applicable
Conclusion:
Not applicable
