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K. Minato
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P1.06 - Poster Session with Presenters Present (ID 458)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.06-021 - Treatment Patterns and Healthcare Resource Use from a Retrospective Cohort of Japanese Patients with Advanced Non-Small Cell Lung Cancer (ID 4632)
14:30 - 14:30 | Author(s): K. Minato
- Abstract
Background:
The treatment landscape for advanced/metastatic non-small cell lung cancer (NSCLC) has changed with the advent of targeted therapies and the use of companion diagnostics.
Methods:
The primary objective of this multi-site, retrospective, chart review study was to describe the treatment patterns, Biomarker (Bmx) testing practices and health care resource use (HCRU) in patients who initiated first line therapy (1LT) for newly diagnosed Stage IIIB/IV NSCLC between January 2011 - July 2013 in Japan. Data were analyzed descriptively. Overall survival (OS) was estimated using the Kaplan-Meier method.
Results:
Of the 175 Japanese patients 70% were male, 19% non- smokers, mean age of 68.8 years (SD=7.75), 83% stage IV and 74 % (n=129) with non-squamous (NSq) histology. 60% (n=105) received second line therapy (2LT) and 31% (n=55) received third line + therapy (3L+T). 85% (n=110) of the NSq and 40% (n=17) of the squamous (Sq) patients received at least one Bmx test. 81% (n=105) and 19% (n=25) of NSq patients, and 40% (n=17) and 24% (n=4) of Sq patients received an EGFR and ALK test, respectively. EGFR Tyrokinase Inhibitors were most commonly used among NSq EGFR mutated patients (n=44) across all lines. 86% (n=38) of the patients used Gefitinib in 1LT and Erlotinib was used in 2LT (n=11 of 30, 37%) and 3LT (n=9 of 15, 60%) patients. All ALK positive patients (n=2) in 1L received anti-ALK therapy (Crizotinib). Among NSq EGFR/ALK negative or unknown patients (n=83), 89% (n=74) received platinum combinations, most commonly carboplatin+paclitaxel (n=22, 26.5%). Single agents (n=29, 67% and n=11, 50%) were commonly used in NSq EGFR/ALK negative or unknown patients receiving 2LT (n=43) and 3LT (n=22); most commonly docetaxel (n=15, 35% & n=5, 23%). Majority of the 1LT patients with Sq histology (36/43, 84%) received platinum combinations therapy; most commonly carboplatin+paclitaxel (51%). Among 2LT, 67 % (n=20) received a single agent, most commonly docetaxel (n=14, 47%). Single agents were commonly used in 73% (n=11) of the patients receiving 3L+T. Overall, the average length of stay, regardless of line of therapy, was 24.6 days per admission. Duration of treatment was longest for 1LT (mean [SD] 140 [175] days), followed by 2LT (66 [129] days) and 3L+T (65 [83] days).Median OS for Japan from start of 1LT & 2LT was 9.9 and 4.7 months, respectively.
Conclusion:
NSq patients are frequently tested for Bmx in Japan. Treatment is personalized according to mutation status and is in concordance with recommended guidelines.
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P1.07 - Poster Session with Presenters Present (ID 459)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: SCLC/Neuroendocrine Tumors
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.07-048 - Clinical Impact of the Relationship between Post-Progression Survival and Overall Survival in Extensive Disease Small Cell Lung Cancer Patients (ID 4303)
14:30 - 14:30 | Author(s): K. Minato
- Abstract
Background:
The effects of first-line chemotherapy on overall survival (OS) might be confounded by subsequent therapies in patients with small-cell lung cancer (SCLC). Therefore, by using individual-level data, we aimed to determine the relationships between progression-free survival (PFS) or post-progression survival (PPS) and OS after first-line chemotherapies in patients with extensive disease SCLC (ED-SCLC) treated with carboplatin plus etoposide.
Methods:
Between July 1998 and December 2014, we analyzed 63 cases of patients with ED-SCLC who were treated with carboplatin and etoposide as first-line chemotherapy. The relationships of PFS and PPS with OS were analyzed at the individual level.
Results:
Spearman rank correlation analysis and linear regression analysis showed that PPS was strongly correlated with OS (r = 0.90, p < 0.05, R[2 ]= 0.71) and PFS was moderately correlated with OS (r = 0.72, p < 0.05, R[2] = 0.62). Type of relapse (refractory/sensitive) and the number of regimens administered after disease progression after the first-line chemotherapy were both significantly associated with PPS (p < 0.05).
Conclusion:
PPS has a stronger relationship with OS than does PFS in ED-SCLC patients who have received first-line chemotherapy. In addition, type of relapse (refractory/sensitive) after first-line treatment and the number of additional regimens after first-line treatment are significant independent prognostic factors for PPS. These results suggest that treatments administered after first-line chemotherapy affect the OS of ED-SCLC patients treated with carboplatin plus etoposide.
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P2.02 - Poster Session with Presenters Present (ID 462)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Locally Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.02-027 - A Randomized Phase II Trial of S-1 plus Cisplatin or Docetaxel plus Cisplatin with Concurrent Thoracic Radiotherapy for Stage III NSCLC: TORG1018 (ID 4164)
14:30 - 14:30 | Author(s): K. Minato
- Abstract
Background:
Concurrent chemoradiotherapy (CCRT) is the current standard treatment for inoperable stage III non-small cell lung cancer (NSCLC), and a clearly superior regimen has not yet been identified. This study was conducted to evaluate cisplatin with S-1 (SP) or docetaxel (DP) with concurrent thoracic radiotherapy in patients with inoperable stage III NSCLC.
Methods:
In this open-label, non-comparative phase II trial, patients with inoperable stage IIIA/B NSCLC were randomized (1:1) to SP (S-1 40 mg/m[2] twice a day on days 1-14 and 29-42, and cisplatin 60 mg/m[2] on days 1 and 29) or DP (docetaxel 50 mg/m[2] and cisplatin 60 mg/m[2 ]on days 1 and 29), stratified by institution, gender, histology, and stage. In both arms, concurrent radiotherapy was started on day 1 (total 60 Gy in 30 fractions). After CCRT, patients in each group received two additional cycles of consolidation chemotherapy with the same regimen as that for the CCRT part. The primary endpoint was the 2-year overall survival (OS) rate, and secondary endpoints were OS, progression-free survival (PFS), toxicity profile, dose intensity and objective response rate (ORR).
Results:
Between May 2011 and August 2014, 110 patients from 19 institutions were enrolled. Finally, 106 patients (56 in each arm) were evaluable for efficacy and safety. The patient characteristics were: male/female, 83/23; median age, 65 (range 42-74) yr; performance status 0/1, 59/47; IIIA/IIIB, 59/47. After a median follow-up of 23.1 months, ORR and median PFS were 71.7% (95%CI: 57.7-83.2) and 11.5 months (95%: 9.00-14.1) in the SP arm, and 67.9% (95%CI: 53.7-80.1) and 17.2 months (95%: 9.62-24.0) in the DP arm, respectively. Grade 3-4 leukopenia (34.0%/62.3%) and neutropenia (28.3%/56.6%) were significantly higher in the DP arm than in the SP arm. Incidences of non-hematological toxicity including febrile neutropenia, anorexia, nausea, diarrhea, radiation pneumonitis and esophagitis tended to be high in the DP arm. No treatment-related death occurred.
Conclusion:
At this preliminary stage, it appears that although the DP arm may have more toxic effects than the SP arm, it has a favorable PFS. The OS data will be available soon.
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P3.02c - Poster Session with Presenters Present (ID 472)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02c-015 - Phase II Trial of S-1/Cisplatin Combined with Bevacizumab for Advanced Non-Squamous Non-Small Cell Lung Cancer: TCOG LC-1202 (ID 4487)
14:30 - 14:30 | Author(s): K. Minato
- Abstract
Background:
S-1 plus cisplatin is a standard chemotherapy regimen for advanced non-small cell lung cancer (NSCLC) (Ann. Oncol. 2015; 26:1401-8). The addition of bevacizumab significantly improved overall survival (OS) in patients with advanced non-squamous (non-SQ) NSCLC who received carboplatin plus paclitaxel but failed to show an OS advantage in patients who received cisplatin plus gemcitabine. Few studies of bevacizumab have evaluated quality of life (QOL) in patients with non-SQ NSCLC.
Methods:
Chemotherapy-naïve patients with stage IIIB, IV, or recurrent non-SQ NSCLC, Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0–1, age 20–74 years, and measurable lesions were treated with a 3-week cycle of S-1 40 mg/m[2] twice a day on days 1–14, cisplatin 60 mg/m[2] on day 8, and bevacizumab 15 mg/kg on day 8, for 4–6 cycles. Patients without progressive disease received maintenance bevacizumab 15 mg/kg on day 1 with a 3-week cycle and S-1 40 mg/m[2] twice a day every other day. The primary endpoint was progression-free survival (PFS). Secondary endpoints were objective response rate (ORR), OS, toxicity profile, and QOL.
Results:
From June 2013 to January 2015, 39 evaluable patients were enrolled from 8 institutions: 10 women and 29 men; median age 65 (range, 38–74) years; epidermal growth factor receptor positive/anaplastic lymphoma kinase positive: two patients/two patients; performance status 0/1: 22/17; stage IIIB/IV/recurrence: 1/35/3; adeno/large cell/other: 35/1/3. Thirty one patients (80%) completed 4 cycles of induction chemotherapy, and 23 patients (59%) were started on maintenance chemotherapy. Median PFS, OS, and ORR were 7.3 months (95% confidence interval (CI): 5.9–8.7), 21.4 months (95% CI: 14.7–not reached), and 64%, respectively. The worst hematologic and non-hematologic adverse events were as follows (%): grade 3/4 leukopenia: 13/0; neutropenia: 18/5; thrombocytopenia: 0/0; anemia: 0/0; neutropenic fever: 3/0; and hypertension: 28/0; diarrhea: 3/0. QOL data will be presented at the meeting.
Conclusion:
S-1 plus cisplatin in combination with bevacizumab met the primary endpoint in patients with advanced non-SQ NSCLC in the present trial. Additionally, the response rate is anticipated to be high, and the regimen was well tolerated. Clinical trial information: UMIN000009476
