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J. Lafitte
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ORAL 34 - Quality/Survival/Prognosis in Localized Lung Cancer (ID 153)
- Event: WCLC 2015
- Type: Oral Session
- Track: Treatment of Localized Disease - NSCLC
- Presentations: 1
- Moderators:B.C. Cho, R.L. Keith
- Coordinates: 9/09/2015, 16:45 - 18:15, 201+203
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ORAL34.01 - Compliance with Follow-Up Programs After Surgery for Non-Small Cell Lung Cancer in the Phase III IFCT-0302 Trial (ID 2148)
16:45 - 18:15 | Author(s): J. Lafitte
- Abstract
- Presentation
Background:
In patients operated on for non-small cell lung cancer, several guidelines recommend a follow-up based on regular clinic visits and chest CT-scans. However, evidence to support these recommendations is poor, in the absence of randomized data. The IFCT-0302 trial is a randomized multicenter trial which compared 2 follow-up programs after complete resection for a clinical stage I, II, IIIA and T4 (pulmonary nodules in the same lobe) N0-2 NSCLC (TNM 6[th] edition). We present the results of compliance with the follow-up programs for the first 2 years after randomization.
Methods:
In the CXR arm, follow-up consisted of clinic visit and chest X-rays. In the CCT arm, patients underwent clinic visit, chest X-rays, thoraco-abdominal CT scan plus fiberoptic bronchoscopy (only mandatory for squamous cell and large cell carcinomas). In both arms, procedures were repeated every 6 months after randomization during the first 2 years, and yearly until 5 years, in the absence of recurrence or second primary cancer. Supplementary procedures were allowed in case of symptoms. Primary endpoint was overall survival.
Results:
Between January 2005 and November 2012, 1775 patients were randomized (CXR: 888; CCT: 887). Patient characteristics were well balanced between the two arms : males 76.3%, median age 62 years (range: 33-87), adenocarcinomas 56.7%, stage I-II 82.1%, lobectomy or bilobectomy 86,8%, pre- and/or post-operative radiotherapy 8.7%, and pre- and/or post-operative chemotherapy 45%. Surveillance was performed in 97% of patients at 6 months, in 94% at 12 months, in 90% at 18 months and in 84% at 24 months, and did not differ between the 2 arms. Intervals between randomization and visits were respected with no difference between arms (mean +/-SD in months from randomization: 5.93 +/- 0.84; 11.95 +/- 0.98; 18.05 +/- 0.99; 24.18 +/-1.30, respectively). In the 757 patients of the CXR arm, who had a follow-up visit at 6 months and no recurrence, 754 (99.6%) had a clinic visit and 730 (96.4%) a chest X-ray. In the 706 patients of the CCT arm who had a follow-up visit at 6 months and no recurrence, 702 (99.4%) had a clinic visit, 478 (67.7%) a chest X-ray, 678 (96%) a chest CT-scan, and 342 (48.4%) a bronchoscopy. Comparable compliance results were observed at 12, 18 and 24 months. In the CXR arm, supplementary thoracic CT-scans were done in 119 patients (15.7 %) at 6 months, in 96 (14.4 %) at 12 months, in 78 (13.2%) at 18 months and in 58 (11.4%) at 24 months. Other supplementary procedures were more frequent in the CCT arm than in the CXR arm, consisting mostly of brain imaging (at 6 months, in 93 (13.2%) and 39 (5.2%) patients, respectively, p<.001).
Conclusion:
Compliance with the follow-up programs was excellent in terms of timing. Chest X-ray was often omitted in the CCT arm. In the CXR arm, supplementary CT-scans that did not lead to a diagnosis of recurrence or second primary cancer were performed in 10 to 15% of patients. In the CCT arm, the most frequently performed supplementary procedure was brain imaging.
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P2.07 - Poster Session/ Small Cell Lung Cancer (ID 222)
- Event: WCLC 2015
- Type: Poster
- Track: Small Cell Lung Cancer
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.07-005 - AVE plus Valproate for Refractory/Relapsing SCLC: A Phase II Study by the ELCWP (ID 142)
09:30 - 17:00 | Author(s): J. Lafitte
- Abstract
Background:
Salvage chemotherapy (CT) for relapsing or refractory small cell lung cancer (SCLC) to platinum-etoposide remains disappointing. In vitro experiments are suggesting that valproic acid, by inhibiting histone deacetylases (HDAC), could increase apoptosis of SCLC cell lines exposed to doxorubicin, vindesine and bis(2-chloroethyl)amine. The primary objective of this phase II study is to determine if epigenetic modulation with valproic acid in addition to a doxorubicin, vindesine, cyclophosphamide (AVE) regimen may allow adequate improved 6-months progression-free survival (PFS) in refractory/relapsing SCLC.
Methods:
Patients (pts) with previously pathologically proven SCLC, either primary or secondary refractory to prior chemotherapy regimen including platinum derivatives and etoposide, Karnofsky performance status ≥ 60, adequate haematological, hepatic, renal, lung and cardiac functions were eligible. After central registration, pts received AVE (doxorubicin 45 mg/m², vindesine 3 mg/m², cyclophosphamide 1 g/m² every 3 weeks) plus daily oral valproic acid to obtain serum concentration in the range of the recommended values for the treatment of epilepsy (50-100 μg/ml). Response was assessed after 3 courses and responders continued treatment until best response, unacceptable toxicity or cumulative dose of doxorubicin > 500 mg/m². The trial was designed to show that 6-months PFS was > 18%, powering the trial to detect an increase to at least 39%. With this assumption, at least 43 pts assessable for PFS had to be registered (a 10%, b 10%).
Results:
From 11/2008 to 12/2013, 64 pts were registered of whom 6 were ineligible. The main characteristics of the 58 eligible pts were: male/female 38/20 pts, PS 60-70/80-100 17/41 pts, median age 60 years, 19 pts received two or more previous lines of CT. Seven pts did not receive any CT leaving 51 pts assessable for the primary endpoint. Objective response rate was 19.6% (95% CI 8.7%-30.5%). Median PFS was 2.75 months (95% CI, 2.46 to 3.61) and 6-months PFS was 6%. Median survival time was 5.9 months (95% CI, 4.7 to 7.5) with 6 and 12-months survival rates of 50% and 6%. As expected, toxicity was mainly haematological with 88% and 26% grade 3-4 neutropenia and thrombopenia, respectively.
Conclusion:
Despite an interesting response rate, the addition of valproic acid to AVE did not translate into adequate PFS in relapsing/refractory SCLC to platinum/etoposide. This regimen cannot be recommended for further investigation.
