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K. Tanaka
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MO03 - Thymic Malignancies (ID 123)
- Event: WCLC 2013
- Type: Mini Oral Abstract Session
- Track: Medical Oncology
- Presentations: 1
- Moderators:F. Detterbeck, M. Okumura
- Coordinates: 10/28/2013, 10:30 - 12:00, Bayside Gallery B, Level 1
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MO03.10 - A multicenter prospective study of carboplatin and paclitaxel for advanced thymic carcinoma: West Japan Oncology Group 4207L (ID 987)
11:25 - 11:30 | Author(s): K. Tanaka
- Abstract
- Presentation
Background
Thymic carcinoma (TC) is a rare malignant tumor originated within the thymus gland and is associated with a poor prognosis, differing from thymoma which is the most common type of thymic malignant neoplasm. No results of clinical trials focusing on TC have been reported. This single-arm study evaluated carboplatin and paclitaxel (CbP) in previously untreated patients (pts) with advanced TC.Methods
Pts with Masaoka’s stage III to IVb TC, ECOG PS 0 to 1, and more than 20 years old were eligible. The study treatment consisted of carboplatin (AUC 6) and paclitaxel (200 mg/m2) every 3 weeks for a maximum of 6 cycles. The primary endpoint was objective response rate (ORR) by extramural assessment. Secondary endpoints included overall survival (OS), progression-free survival (PFS), and safety. All pts were followed-up until 24 months (mo) after last enrollment. Based on the SWOG 2-stage design, the planned sample size of 40 pts was determined to reject the ORR of 20% under the expectation of 40% with a power of 0.85 and a type I error of 0.05.Results
From May 2008 to November 2010, 40 pts were enrolled from 21 centers. Of 39 evaluable for analysis, the median age was 62 years (range, 36–84); 23/16 males/females; 3/10/26 with Masaoka’s stage III/IVa/IVb; 9/11/19 with squamous cell carcinoma/poorly differentiated neuroendocrine carcinoma/other types. The median number of cycles was 6. There was 1/13 complete/partial responses with an ORR of 36% (95% confidence interval [CI], 21-53%; P = 0.031). The median PFS was 7.5 mo (6.2-12.3 mo) while OS did not reach the median value. The 1-year and 2-year survival rates were 85% (95% CI, 69-93%) and 71% (95% CI, 54-83%), respectively. Major adverse event was grade 3-4 neutropenia in 34 pts (87%). Two cases (5%) of grade 3 febrile neutropenia, neuropathy, and arthralgia were observed, respectively. There was no treatment-related death.Conclusion
CbP showed high efficacy in advanced TC. Our results established that CbP, one of the standard treatments for non-small cell lung cancer, also serves as a key chemotherapy regimen for TC.Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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P2.14 - Poster Session 2 - Mesothelioma (ID 196)
- Event: WCLC 2013
- Type: Poster Session
- Track: Mesothelioma
- Presentations: 1
- Moderators:
- Coordinates: 10/29/2013, 09:30 - 16:30, Exhibit Hall, Ground Level
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P2.14-003 - Phase I and pharmacokinetic study of amatuximab, a novel chimeric antibody to mesothelin, in patients with advanced solid tumors (ID 1209)
09:30 - 09:30 | Author(s): K. Tanaka
- Abstract
Background
Amatuximab is a chimeric monoclonal antibody to mesothelin. Mesothelin, a membrane protein, is a potential target for molecular targeted therapy due to its high expressions in virtually all pancreatic cancers and mesotheliomas as well as several cancers, while showing little expression in normal tissues, except for normal mesothelium. Amatuximab inhibits the growth of mesothelin-expressing human tumors in vitro and in vivo xenograft model.Methods
To investigate dose-limiting toxicities (DLTs) and estimate the maximum tolerated dose (MTD) of amatuximab in Japanese patients with advanced solid tumors. In addition, pharmacokinetics of amatuximab, human anti-chimeric antibody (HACA) and mesothelin expression by immunohistochemistry (IHC) were investigated. Patients with pancreatic cancers, mesotheliomas, or mesothelin-positive solid tumors as assessed by the IHC test, who have no other appropriate treatment were eligible in the study. Amatuximab was administered weekly until disease progression or occurrence of a DLT, and administered to 3 cohorts at 50, 100 and 200 mg/m[2] in a step-wise dose escalation manner. The pharmacokinetic parameters were calculated by model independent analysis and the dose proportionality was investigated on Cmax and AUC (0-t) values.Results
58 patients were screened and a total of 17 patients were enrolled consisting of seven colorectal cancer, six pancreatic adenocarcinoma, two mesothelioma and two head and neck cancer (seven patients in 50 mg/m[2], three in 100 mg/m[2] and seven in 200 mg/m[2], respectively). Two DLTs were observed (grade 3 cytokine release syndrome in 50 mg/m[2] and grade 5 interstitial lung disease in 200 mg/m[2]). Treatment related adverse events were observed in 13 of 17 patients, and the most common events were grade 1 fatigue (five patients) and pyrexia (four patients). Amatuximab was eliminated from serum biphasically after reached Cmax. Estimated mean T1/2 on Cycle 1 Day 1 was 92.3 to 108 h and CL was 11.7 to 15.2 mL/h/m[2]. It was found that the Cmax and AUC (0-t) values on Cycle 1 Day 1 increased in an almost dose proportional manner and these were similar to those in US patients. HACA was detected in eight of 17 patients. Of 53 patients whose tissue samples were evaluated by IHC, 24 patients (45.3%) were mesothelin-positive (10 of 19 patients in colorectal cancer, four of eight in biliary cancer, four of five in pancreatic adenocarcinoma and six of 21 in other cancers).Conclusion
Amatuximab was well tolerated in patients with advanced solid tumors, and MTD was not reached up to 200 mg/m[2]. Pharmacokinetic profile of amatuximab in Japanese patients was similar to that in US patients. Amatuximab is currently being investigated for its potential treatment of mesothelioma.
