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H. Daga
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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): H. Daga
- 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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O07 - Supportive and Surgical Care (ID 136)
- Event: WCLC 2013
- Type: Oral Abstract Session
- Track: Surgery
- Presentations: 1
- Moderators:M. Culligan, K.A. Mooney
- Coordinates: 10/28/2013, 10:30 - 12:00, Bayside Gallery A, Level 1
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O07.01 - Randomized phase III trial of aprepitant compared with dexamethasone for emesis induced by carboplatin (ID 1261)
10:30 - 10:40 | Author(s): H. Daga
- Abstract
- Presentation
Background
Carboplatin (CBDCA) is used widely against various tumors,including non-small cell lung cancer, small cell lung cancer, which is classified a moderate emetic risk. 5-HT~3~ antagonist and corticosteroid had a great efficacy in patients (pts) treated with CBDCA containing chemotherapy. This randomized trial was conducted to evaluate the efficacy and safety of aprepitant (APR) compared with corticosteroid, based on granisetron (GRA) plus corticosteroid at the first day, in pts treated with CBDCA containing chemotherapy.Methods
Pts treated with CBDCA (AUC 5 or 6) containing chemotherapy were entered on this trial. Major eligible criteria included more than 20 years old, and ECOG PS 0-2. Patients were randomized either A group (GRA 3 mg, iv, day 1, dexamethasone [DEX] 3.3 mg, iv, day 1, APR 125 mg , po, day 1, and APR 80 mg, po, days 2,3) or D group (GRA 3 mg, iv, day 1, D EX 6.6 mg, iv, day 1, and DEX 8 mg, po, days 2, 3). Randomization was stratified by gender and CBDCA AUC 5 or 6. Study period was 120 hours from administration of CBDCA. During this period, pts recorded the time and date of emetic episodes and severity of nausea by themselves in a survey form. Primary endpoint was complete response rate (CRR), defined as no emetic episodes and no rescue medications during the overall study period. Secondary endpoints included CRR during the acute (0-24 h) and the delayed (24-120 h) phases, no nausea rate, severity of nausea and safety. The planned sample size of 128 provided 80% power to detect a 20% improvement in the CRR at overall period with two-sided α of 0.1. This study was approved by the institutional review board in our institution. All pts provided written informed consent prior to enrollment.Results
From October 2010 to August 2012, 128 pts were entered in this phase III trial. Three quarters of entered pts were male, and 63% were received CBDCA AUC 6. Baseline factors, such as age, gender, AUC of CBDCA, chemotherapy regimen, and PS, were well balanced between the two groups. The CRR during overall study period were 61.3% and 68.8% in A and D group, respectively (p=0.3799). There was no difference of CRR during both the acute phase (98.4% vs 98.4%) and the delayed (61.3% vs 68.8%). There was no adverse event due to the antiemetic therapy in both groups during the overall study period.Conclusion
This randomized phase III trial failed to demonstrate that APR was superior to DEX for emesis induced by CBDCA containing chemotherapy which was classified a moderate emetic risk. Combination APR with DEX on days 2 and 3, or more was likely to increase an antiemetic efficacy during delayed phase. Further study was warranted.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.
