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Y. Hosomi
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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): Y. Hosomi
- 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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P2.06 - Poster Session with Presenters Present (ID 467)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Scientific Co-Operation/Research Groups (Clinical Trials in Progress should be submitted in this category)
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.06-018 - Multicenter, Single-Arm Phase II Study of Nab-Paclitaxel/Carboplatin in Untreated PS2 Patients with Advanced NSCLC: TORG1426 (ID 4805)
14:30 - 14:30 | Author(s): Y. Hosomi
- Abstract
Background:
No standard of care exists for ECOG Performance Status (PS) 2 patients with advanced non-small cell lung cancer (NSCLC) and therefore clinical practice ranges from supportive care to combination chemotherapy. It was first reported that the combination therapy with carboplatin (CBDCA)/pemetrexed significantly improved survival for PS2 patients with advanced non-squamous NSCLC (J Clin Oncol 31:2849-2853.2013). However, due to the limited utilities of this regimen, establishment of other combination therapy is warranted in PS2 patients with especially squamous NSCLC or unfavorable renal function. On the other hand, in CA031 trial, CBDCA/nab-paclitaxel (PTX) demonstrated a significantly higher response rate (RR) compared with CBDCA/PTX in PS0-1 patients with advanced NSCLC, especially squamous histology (J Clin Oncol 30:2055-2062.2012). Furthermore, in elderly patients over 70 years old, CBDCA/nab-PTX tended to show superior PFS and OS on the basis of better tolerability compared with CBDCA/PTX. Thus, CBDCA/nab-PTX could be a valid treatment option for PS2 patients whose PS is exacerbated due to mass effect of NSCLC despite appropriate organ function.
Methods:
This phase 2 trial is enrolling untreated PS2 patients with NSCLC and appropriate organ function under 75 years old. Patients are included if they had histologically/cytologically confirmed stage IIIB/IV NSCLC unfit for surgery or radiotherapy, whereas they are excluded if they had uncontrolled symptomatic brain metastasis or uncontrolled pleural effusion. The primary endpoint is PFS rate at 6months. Achievement of more than 50% is considered worthy of further development of this combination therapy, whereas that of less than 30% is considered insufficient for further investigation. The estimated power of this design is 80% with a type I error of 0.05, resulting in 35 patients needed. Considering that about 20% of patients are likely to be excluded from the trial, we planned to enroll 45 patients. Patients are treated with nab-PTX (70 mg/m[2] on day1, 8, and15, q4w) and CBDCA (AUC 5 on day1, q4w), up to 6 cycles. Concurrently, Quality of life and Charlson Comorbidity Index are planned to be checked about the patients treated with this regimen. This study is open for enrollment and recruitment is ongoing. Clinical trial information: UMIN000019458.
Results:
Section not applicable
Conclusion:
Section not applicable
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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): Y. Hosomi
- 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
