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T. Kato
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ORAL 01 - Chemotherapy Developments for Lung Cancer (ID 88)
- Event: WCLC 2015
- Type: Oral Session
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:G. Blumenschein, S. Lee
- Coordinates: 9/07/2015, 10:45 - 12:15, 401-404
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ORAL01.01 - Randomized Phase III Study of Nedaplatin plus Docetaxel versus Cisplatin plus Docetaxel for Advanced Squamous Cell Lung Cancer (WJOG5208L) (ID 621)
10:45 - 10:56 | Author(s): T. Kato
- Abstract
- Presentation
Background:
Nedaplatin (N) is a second-generation platinum compound with lower nausea/vomiting and nephrotoxicity than cisplatin (C). Nedaplatin plus docetaxel (ND) showed a promising efficacy with acceptable toxicity for advanced squamous cell lung cancer (SqLC) in the previous phase II study.
Methods:
Eligible patients (pts) were those with pathologically proven SqLC with stage IIIB/IV or postoperative recurrence, aged 20-74 years and ECOG PS 0-1. Pts were randomized 1:1 to ND (N 100 mg/m[2] and docetaxel (D) 60mg/m[2] iv, q3w, up to 6 cycles) or C plus D (CD) (C 80 mg/m[2] and D 60mg/m[2] iv, q3w, up to 6 cycles) according to stage, gender and institution. The primary endpoint was overall survival (OS), and secondary endpoints included progression-free survival (PFS), response rate (RR) and adverse events (AEs). Target sample size of 350 provided 90% statistical power to detect a hazard ratio of 0.71 with one-sided type I error of 0.05.
Results:
Between July 2009 and July 2012, 355 pts were randomized. Of 349 for efficacy analysis (ND 177; CD 172), baseline characteristics were well-balanced between two arms. ND had a significantly longer OS (p=0.037, one-sided stratified log-rank test). The OS HR was 0.81 (90%CI, 0.67-0.98) with a median OS of 13.6 months [m] for ND and 11.4 for CD. ND had a longer PFS (p=0.050) with a HR of 0.83 (0.69-1.00) and a median PFS of 4.9 m in ND and 4.5 in CD. RR was 54.5% in ND vs 52.9% in CD (p=0.829). Grade 3 or higher AEs of nausea (4.0% vs 14.3%), fatigue (3.4% vs 10.9%), hyponatremia (13.6% vs 30.3%) and hypokalemia (2.3% vs 8.6%) are more frequent in CD. Grade 3 or higher AEs of neutrophils (82.5% vs 70.3%) and platelets (9.0% vs 0.0%) are more frequent in ND, but there was no difference in grade 3 or higher febrile neutropenia (13.6% vs 15.4%). Treatment related deaths occurred in 4 and 3 pts in ND and CD, respectively.
Conclusion:
ND showed a significantly longer OS as compared to CD with different toxicity profile. ND will be considered as a new standard treatment for advanced or relapsed SqLC. Clinical trial information: UMIN000002015.
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P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 2
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.01-056 - Phase II Study of Carboplatin plus Weekly Nab-Paclitaxel in Elderly Patients with NSCLC: North Japan Lung Cancer Study Group Trial 1301 (ID 576)
09:30 - 09:30 | Author(s): T. Kato
- Abstract
Background:
Recent IFCT-0501 trial demonstrated that carboplatin (CBDCA) combined with weekly paclitaxel (PTX) would be advantageous compared with monotherapy. Subsequently, CA031 trial suggested that weekly nab-paclitaxel (nab-PTX) was superior in efficacy and safety compared with 3-weekly PTX when combined with CBDCA. Since the subgroup analysis for elderly patients (pts) in CA031 showed very promising data (34% of overall response rate (ORR) and 8.0 months of progression-free survival (PFS)), we conducted this multicenter, non-randomized, open label, phase II trial to evaluate the efficacy and tolerability of CBDCA plus weekly nab-PTX regimen for elderly patients with advanced non-small cell lung cancer (NSCLC) prospectively.
Methods:
Eligible pts were aged 75 years or older with newly diagnosed clinical stage IIIB, IV, and postoperative recurrence NSCLC; ECOG performance status (PS) of 0-1; adequate organ function; written informed consent. Pts received CBDCA (AUC 6) on day 1 and nab-PTX (75mg/m[2]) on day1, 8, and 15, every 4 weeks. The primary endpoint was ORR and secondary endpoints were PFS, overall survival (OS), and toxicity profile. Assuming that ORR of 40% would be potential usefulness while ORR of 20% would be the lower limit of interest, 32 pts were required.
Results:
Between March 2013 and May 2014, 35 pts were enrolled and 32 pts were eligible. Median age was 78 years (range, 75-86), 84% (27/32) were male and 56% (18/32) were stage IV. 56% (18/32) had squamous cell carcinoma and 44% (14/32) had adenocarcinoma. Median treatment cycle was 4 (range, 1-6). ORR and DCR were 50% (95%CI: 33-67) and 94% (95%CI: 85-100), respectively. With a median follow-up of 9.1 months, median PFS was 6.4 months (95%CI: 4.8-8.0). Median OS had not been reached at the data cutoff point. Grade 3 or severer toxicities were as follows: neutropenia (47%), leukopenia (38%), anemia (34%), thrombocytopenia (25%), and anorexia (9%). No febrile neutropenia and treatment-related deaths were observed.
Conclusion:
The combination of CBDCA and weekly nab-PTX demonstrated significant efficacy with acceptable toxicities in elderly patients with advanced NSCLC.
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P3.01-085 - Randomized Phase II Study of Docetaxel plus Bevacizumab or Pemetrexed plus Bevacizumab for Elderly Non-Squamous NSCLC (TORG1323) (ID 1742)
09:30 - 09:30 | Author(s): T. Kato
- Abstract
Background:
A randomized study comparing carboplatin plus weekly paclitaxel versus single-agent chemotherapy in elderly patients with non-small cell lung cancer (NSCLC) demonstrated a survival advantage for combination therapy, however, increased toxicity and treatment-related deaths were also observed. Thus, single agent approaches remain the standard of care and the improvement of treatment remains a challenge in elderly patients. The combination of bevacizumab and other platinum-based chemotherapies is the standard of care in non-elderly patients with non-squamous NSCLC. Additionally, a randomized phase II study suggested the improvement of efficacy for the combination of B plus single-agent pemetrexed or docetaxel compared with single-agent alone. Even in elderly patients, two prospective studies which we conducted demonstrated the feasibility of the combination of bevacizumab and single agent pemetrexed or docetaxel. Thus we plan this randomized phase II study (TORG1323) to select the optimal regimen for experimental arm of the future phase III study in elderly patients.
Methods:
TORG1323 is an open label multicenter randomized phase II study to compare docetaxel plus bevacizumab (DB) with pemetrexed plus bevacizumab (PB). The primary endpoint is progression free survival (PFS, assessed by independent review committee). The secondary endpoints are safety, PFS (assessed by investigators), objective response rate, overall survival, time to treatment failure and quality of life. Eligible patients are 75 years or older, have histologically or cytologically documented stage IIIb, IV or recurrent non-squamous NSCLC for which they had no received chemotherapy, ECOG performance status 0 or 1, and adequate organ function. Patients are randomly assigned to PB and DB arm (1:1). Bevacizumab is administered 15 mg/kg, pemetrexed is 500 mg/m[2] and docetaxel is 50 mg/m[2] every 3 weeks until disease progression or unacceptable toxicity. Selection design is adopted for this study. The planned sample size is 120 patients to yield 80 % power to select an optimal regimen correctly. Enrollment time is 2 years 8 months and follow-up time is 1 year. The first patient on this clinical trial was enrolled in April 2014. Further details can be found on UMIN Clinical Trials Registry (UMIN000012786). Figure 1
Results:
not applicable
Conclusion:
not applicable
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P3.07 - Poster Session/ Small Cell Lung Cancer (ID 223)
- Event: WCLC 2015
- Type: Poster
- Track: Small Cell Lung Cancer
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.07-015 - Final Report of Phase I/II Study of Induction Carboplatin and Irinotecan Followed by TRT for Elderly Patients with LD-SCLC: TORG 0604 (ID 3232)
09:30 - 09:30 | Author(s): T. Kato
- Abstract
Background:
In elderly patients with LD-SCLC, the role of irinotecan has been unclear and the timing of TRT combined with chemo-therapy has not been fully evaluated. Furthermore, no standard treatment has been established for them. We report a phase I/II trial of induction chemotherapy of carboplatin and irinotecan followed by sequential TRT in this population.
Methods:
Patients with untreated, measurable LD-SCLC >70 years with performance status (PS) 0 to 2 and adequate organ function were eligible. Treatment consisted of induction with carboplatin on day 1 and irinotecan on days 1 and 8 every 21 days for four cycles. TRT of 54Gy in 27 fractions was then administered sequentially. Carboplatin dose was escalated from AUC of 4 to 5 (Levels 1 and 2, respectively) with a fixed dose of irinotecan at 50 mg/m[2]. The primary objective of the phase II portion was evaluation of efficacy.
Results:
A total of 41 patients were enrolled [median age 75 years, range 70-86 years; 31 male, 10 female; PS 0/1/2: 22/18/1]. At Level 1 (n=6), one patient experienced dose-limiting toxicity (DLT) as Grade 3 hypertension. At Level 2 (n=6), two patients experienced DLT as Grade 4 thrombocytopenia. Therefore, level 1 was chosen as the recommended dose. The phase II trial was then expanded by 35 patients in the level 1 based on the Simon minimax design. In all cohorts, the median chemotherapy cycle was 4 (1/2/3/4 courses administered as 4/2/2/33); median radiation dose was 54Gy (range 36-60). Toxicities were generally mild, as expected. Gr 3/4 leukopenia and thrombocytopenia were both observed in six (15%) patients. No Gr 3/4 diarrhea or esophagitis was noted. Although Gr 3 febrile neutropenia and Gr 3 pneumonitis were seen in two patients each, no treatment-related deaths occurred. There were five complete responses and 32 partial responses, for a response rate of 90%. With median follow-up of 80.4 months (n=41), median progression-free and overall survival times were 11.2 and 27.1 months, respectively.
Conclusion:
Induction chemotherapy with carboplatin plus irinotecan followed by sequential TRT was well tolerated and highly effective in elderly patients with LD-SCLC. Further confirmatory studies are warranted.
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P3.11 - Poster Session/ Palliative and Supportive Care (ID 231)
- Event: WCLC 2015
- Type: Poster
- Track: Palliative and Supportive Care
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.11-004 - Promising Effect of Olanzapine on Chemotherapy-Induced Nausea and Vomiting Uncontrolled with Conventional Antiemetic Therapy (ID 3103)
09:30 - 09:30 | Author(s): T. Kato
- Abstract
Background:
Chemotherapy-induced nausea and vomiting (CINV) is still a major adverse effect especially for patients treated with highly emetogenic chemotherapy (HEC). In clinical practice, 5-HT3 receptor antagonist, NK-1 receptor antagonist, and corticosteroids are widely used to alleviate emetic episodes during chemotherapy. With those drugs, acute-nausea and vomiting is successfully manageable. However, late-onset nausea and vomiting is sometimes difficult to be controlled and therefore, the promising drugs is needed. Olanzapine is an antipsychotic agent which is approved for schizophrenia and bipolar disorder in Japan. Recently, the combination therapy with olanzapine and the conventional anti-emetic drugs has been reported highly effective to prevent late-onset CIMV after HEC. However, it remains unclear whether olanzapine is really effective for patients who develop acute- or late-onset CIMV after HEC.
Methods:
All consecutive patients, who were treated with HEC and olanzapine at Jichi Medical University Hospital from January 2014 to December 2014, were included. “Antimetic Response” was defined as the absence of nausea and vomitting, no use of breakthrough antiemetic medications, or increased dietary intake (≧50%). The details of clinical information were reviewed from the medical records .
Results:
Among 18 patients treated with HEC and olanzapine as antimetic medication, 11 were males and 7 were females, with a median age of 60.5 years (42-74 years). Primary tumors were non-small cell lung cancer in 11 cases, small cell lung cancer in 5, malignant mesothelioma in one case, and embryonal carcinoma in one case. Olanzapine was used for preventing CINV in 8 patients with the previous experience of late-onset CINV and in 2 patients without, for treating late-onset CINV in 6 patients and acute onset CINV in 2 patients. "Antiemetic response" has been observed in 15 patients (83.3%). Among 8 patients previously experiencing late-onset CINV, "Antimetic response" was obtained in 7 patients(87.5%).
Conclusion:
Our results strongly suggest the olanzapine provides an additional effect on CINV uncontrolled with conventional antiemetic therapy, regardless of whether CINV is acute or chronic.
