Virtual Library
Start Your Search
Tsuneo Shimokawa
Author of
-
+
P2.07 - Immunology and Immunotherapy (ID 708)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Immunology and Immunotherapy
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
-
+
P2.07-042 - Feasibility Study of Nivolumab and Docetaxel in Previously Treated Patients with Advanced Non-Small Cell Lung Cancer (ID 9936)
09:30 - 09:30 | Presenting Author(s): Tsuneo Shimokawa
- Abstract
Background:
Nivolumab (NIV) is a standard second-line treatment for previously treated patients with advanced non-small cell lung cancer (NSCLC). Although there is a possibility that a higher effect can be expected by combination NIV and cytotoxic agents, verification in a clinical trial is required. Because there was only one report of phase Ib trial (N=6) of NIV + docetaxel (DTX) combination (Kanda et al, Ann Oncol 2016), we planned a feasibility study to examine the safety of this combination prior to large scale clinical trials.
Method:
Eligibility criteria included a history of platinum-based chemotherapy, PS 0-1, and adequate organ functions. Patients received NIV 3 mg/kg (days 1, 15) and DTX 60mg/m[2 ](day 1) every 4 weeks for a maximum of 2 courses. The primary endpoint was safety of 1st course and evaluated dose-limiting toxicities (DLT). This study used a 3 + 3 design and was considered to be feasible if DLT occurred in one-thirds or less of the patients. The secondary endpoints were the adverse events and the response rate. DLT was defined in accordance with the phase Ib study of Kanda et al .
Result:
Between Aug 2016 and Sep 2016, three patients were enrolled into this trial in 2 centers in Japan. First case was 57 years old female / adenocarcinoma, 2nd case was 44 years old male / squamous cell carcinoma, 3rd case was 58 years old male / adenocarcinoma. Grade 3 or more adverse events occurred only in one case of Grade 4 neutropenia, and no DLTs were observed in any cases. All patients completed 2 courses and objective tumor responses were PD, SD, PR, respectively. Two of three patients still survive more than 10 months from start of this therapy.
Conclusion:
NIV+ DTX combination therapy was acceptable for safety and further evaluation is warranted. Because the use of combination NIV plus cytotoxic agents is not approved in Japan, we are planning to conduct a phase II / III trial (CONDUCT study) comparing NIV + DTX with NIV alone in previously treated patients with advanced NSCLC in the Thoracic Oncology Research Group (TORG), using an Advanced Medical Healthcare in Japan.
-
+
P2.15 - SCLC/Neuroendocrine Tumors (ID 716)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: SCLC/Neuroendocrine Tumors
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
-
+
P2.15-004 - Underrepresentation of Elderly Patients with ED-SCLC as Clinical Trial Candidates (JCOG1201/TORG1528) (ID 8837)
09:30 - 09:30 | Author(s): Tsuneo Shimokawa
- Abstract
Background:
Since December 2013, we initiated a phase II/III trial [Japan Clinical Oncology Group (JCOG) 1201/Thoracic Oncology Research Group (TORG) 1528: UMIN000012605] for elderly patients with extensive-disease small-cell lung cancer (ED-SCLC). Aim of the study is to demonstrate that a carboplatin plus irinotecan regimen is superior to carboplatin plus etoposide in elderly patients with ED-SCLC. However, the patient accrual rate did not satisfactorily match our expectations a year from the time of initiation of our study. To define factors related to low accrual, we searched institutional records and analyzed.
Method:
We collected data of elderly patients with ED-SCLC from each institution and investigated the total number of elderly patients with ED-SCLC, number of patients eligible/ineligible for the study, numbers of patients registered for the study, and the reasons for non-registration of even eligible patients. Doctor-reported questionnaires concerning elderly (≥71 years old) ED-SCLC patients diagnosed in their institutions were sent to chief or coordinate doctors at each institution in December 2014.
Result:
We received a response from 32 (84%) of 38 institutions. Approximately 260 patients were diagnosed as elderly patients with ED-SCLC in the last year. Only 100 patients (38%) were eligible for the JCOG 1201/TORG1528 trial. Reasons for ineligibility primarily included poor performance status (PS) (25%), low organ functions (25%), interstitial pneumonitis (19%) and double cancer (18%). Only 23 patients among the 100 eligible candidates accrued to the study. The primary reasons for non-accrual were delayed approval from the Institutional Review Board (IRB) of the individual institution (24%), physician preferences (23%), patient refusal (18%), and registration for other trials (12%).
Conclusion:
Our data demonstrated that 62% of ED-SCLC patients were ineligible for the protocol due to frailty with the most frequent reason being comorbidities such as poor PS and low organ functions. However, inactive institutions need to increase their efforts to register a greater number of eligible patients in addition to obtaining quicker IRB approval of protocol. Based on responses to questionnaires sent out as part of our investigation, in January 2016, the protocol was revised in terms of eligibility criteria to enhance patient accrual. Eligibility criteria for participation of elderly patients with ED-SCLC need to be formulated prudently so that patients are benefitted in routine clinical practice.
