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Yuichi Ishikawa
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P1.14 - Thymoma/Other Thoracic Malignancies (Not CME Accredited Session) (ID 946)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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P1.14-03 - Phase II Trial of Amrubicin and Cisplatin Chemotherapy for Invasive Thymoma: WJOG5509L (ID 11706)
16:45 - 18:00 | Author(s): Yuichi Ishikawa
- Abstract
Background
Background: Platinum and anthracycline combination chemotherapy has been considered as the standard treatment for invasive thymoma for a long time. The clinical activity of amrubicin (AMR)—an anthracycline agent—has been previously reported in the treatment of small cell lung cancer (SCLC). The aim of this study was to evaluate the efficacy and safety of the combination of AMR and cisplatin (CDDP) in patients with advanced or recurrent invasive thymoma.
a9ded1e5ce5d75814730bb4caaf49419 Method
Methods: Patients were eligible for inclusion in the study if they met the following criteria: were chemo-naive; not amenable to curative surgery or radiotherapy; and presented with histologically confirmed invasive thymoma in each site. The patients received AMR (35 mg/m2, on days 1–3) and CDDP (60 mg/m2, on day 1) every 3 weeks, for up to 4 cycles. The primary endpoint was the objective response rate (ORR) assessed by an independent review, and the secondary endpoints were overall survival (OS) and toxicity profile of the patients. Based on the SWOG 2-stage design, the planned sample size of 40 patients was determined to reject the ORR of 60% under the expectation of 80% with a power of 0.85 and a type I error of 0.05. This trial is registered with the UMIN Clinical Trials Registry, number UMIN000003933.
4c3880bb027f159e801041b1021e88e8 Result
Results: From August 2010 to November 2014, a total of 26 patients were enrolled at 14 institutions in Japan. During the planned interim analysis in April 2014, the ORR of the 20 patients who had been enrolled so far, was assessed via independent review and found to be 55.6% (11/20), resulting in the early termination of this study because of its futility. In the final assessment, the ORR was 54.2% (95% confidence interval, 32.8–74.4) and the disease control rate was 95.8%. The OS did not reach the median value. The major grade 3 or 4 toxicities noted were neutropenia (96.2%), anemia (26.9%), anorexia (11.5%) and febrile neutropenia (26.9%), albeit these were transient and manageable. There was one treatment-related death.
8eea62084ca7e541d918e823422bd82e Conclusion
Conclusions: The combination of AMR with CDDP had minimal activity on invasive thymoma. Thus, we do not recommend further study of this regimen.
6f8b794f3246b0c1e1780bb4d4d5dc53
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P1.16 - Treatment of Early Stage/Localized Disease (Not CME Accredited Session) (ID 948)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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P1.16-43 - Analyses of Long-Term Outcomes and Prognostic Factors in Surgically Resected ALK-Rearranged Lung Adenocarcinoma (ID 12721)
16:45 - 18:00 | Author(s): Yuichi Ishikawa
- Abstract
Background
Anaplastic lymphoma kinase (ALK)-rearrangement (ALK+) in lung cancer has made an epoch in the molecular classification. Specific inhibitors of the kinase activity of ALK have been developed as therapeutic drugs for lung cancer with ALK+. Long-term outcomes and prognostic factors, however, in surgically resected cases are unclear. We evaluated the survival rate, and investigated association between prognosis of surgically resected lung adenocarcinoma (AC) with ALK+ and clinicopathological features.
a9ded1e5ce5d75814730bb4caaf49419 Method
From 1996 to 2013, clinical data of 62 AC patients with ALK+ were retrospectively analyzed. The median follow up time was 73 months. Relationships between the patients’ clinicopathological features (i.e. age, gender, smoking history, operative procedure, administration of adjuvant therapy, tumor size, c-stage, p-stage, pleural invasion, Ly/V invasion, intrapulmonary metastasis, histologic predominant subtypes, and histologic grade), and their recurrence-free survival (RFS), post-recurrence survival (PRS) and overall survival (OS) rates were assessed.
4c3880bb027f159e801041b1021e88e8 Result
The 5-year RFS and OS were 69% and 92%, respectively. For OS, advanced p-stage (IIIA and IV) and pleural invasion were independent poor prognostic factors in multivariate analyses, but 5-year OS for even Stage IIIA was 85%, nevertheless (Figure).
20 patients had recurrence. 8 of the 20 patients were treated with ALK-tyrosine kinase inhibitors (TKIs), and 12 were without. The median PRS was 54 months. Patients treated with AKL-TKIs had longer PRS and OS than without (65 vs. 38 months, p=0.01, and 80 vs. 74 months, p=0.04, respectively).
8eea62084ca7e541d918e823422bd82e Conclusion
Long-term outcomes in surgically resected ALK+ AC were excellent even so advanced stage. ALK-TKIs are certainly effective for post-recurrence status. For the resectable ALK+ AC treatment strategy, ALK-TKIs might play an important role.
6f8b794f3246b0c1e1780bb4d4d5dc53
