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T. Nakagawa
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MINI 15 - Chemotherapy Developments for Lung Cancer (ID 128)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:L. Crinò, C.P. Belani
- Coordinates: 9/08/2015, 16:45 - 18:15, Mile High Ballroom 1a-1f
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MINI15.02 - NEJ016: Phase II Study of CBDCA and Weekly PTX plus BEV Followed by BEV for Highly Selected Elderly Non-Squamous NSCLC Patients (ID 977)
16:45 - 18:15 | Author(s): T. Nakagawa
- Abstract
- Presentation
Background:
It is considered that there is a population of “fit-elderly” patients, but how to select this population is undetermined. Two-drug regimen consisted of carboplatin (CBDCA) + weekly paclitaxel (PTX) in elderly patients with non-small cell lung cancer (NSCLC) was reported to be active but to have 4.4% of toxic deaths. When considering to add bevacizumab (BEV) to the two-drug regimen, meta-analysis of BEV-related adverse events taught that congestive heart failure (CHF) and arterial thromboembolic events increased in elderly patients. In this phase II study, we employed exclusion criteria of having both congestive heart failure (CHF) and diabetes mellitus (DM), which relates to arterial thromboembolism.
Methods:
Elderly (≥70 years old) patients with chemotherapy-naive, stage IIIB/IV or recurrent non-squamous NSCLC, ECOG-PS 0-1, measurable target lesion, and adequate organ functions were eligible for this study. Pts with CHF (i.e. those with brain natriuretic peptide (BNP) ≥ 100 pg/ml and ejection fraction (EF) ≤ 50%) and with DM (i.e. those with HbA1c ≥ 7.0%) were excluded. Treatment included CBDCA at AUC 5 on day 1, PTX at 90 mg/m[2] on days 1 and 8, and BEV at 15 mg/kg on day 1 of each 21-day cycle for up to 4 cycles, followed by maintenance BEV.
Results:
Thirty-six eligible patients (14 male, 22 female; median age, 75 years) were enrolled between February 2012 and September 2014. Fifteen and 21 patients had ECOG-PS of 0 and 1, respectively. The median number of CBDCA + weekly-PTX + BEV treatment cycles received was 4, and that of BEV maintenance dosing was 5. Grade 3/4 non-hematological and hematological toxicities were observed in 13 (36.1%) and 20 pts (55.6%), respectively. The most common grade 3/4 AEs included neutropenia (52.8%), hypertension (11%), anemia (8.3%), and infection (8.3%). No fatal AE was observed. The response rate, the primary endpoint of this study, was 69.4% (95% CI = 51.9–83.7), and median progression free survival was 9 months.
Conclusion:
CBDCA + weekly PTX + BEV followed by BEV was a feasible and effective first-line regimen for selected elderly non-squamous NSCLC patients. BNP, EF, and HbA1c may aid in selecting “bevacizumab-fit” elderly patients. Clinical information: UMIN000006622.
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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: 1
- 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 - 17:00 | Author(s): T. Nakagawa
- 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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P3.03 - Poster Session/ Treatment of Locoregional Disease – NSCLC (ID 214)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Locoregional Disease – NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.03-021 - Neoadjuvant Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC) Patients (ID 1372)
09:30 - 17:00 | Author(s): T. Nakagawa
- Abstract
Background:
Neoadjuvant chemotherapy (NAC) has gained popularity in recent years, becoming a standard treatment for locally advanced non-small cell lung cancer (NSCLC) to improve resectability and downstage nodal disease, which have clear impacts on prognosis. Potential disadvantages are increased morbidity and/or mortality after surgery and risk of progression of disease that could have been initially resected. The purpose of this study was to evaluate outcomes in a series of patients with locally advanced NSCLC receiving NAC followed by surgery.
Methods:
A total of 12 patients (66.7% males; median age, 71 years) affected by NSCLC in clinical stage IIA-IIIB underwent platinum-based NAC followed by surgery between 2008 and 2014. The clinical stage was IIA in 3 patients, IIIA in 8 (4 of which were IIIAN2), and IIIB in 1. Histology was adenocarcinoma in 8, squamous cell carcinoma in 3, and adenosquamous carcinoma in 1.
Results:
All patients received platinum-based chemotherapy (median, 4 cycles). The NAC regimen was weekly paclitaxel-carboplatin in 6 patients, pemetrexed-carboplatin in 3, paclitaxel-carboplatin-bevacizumab in 2, and gemcitabine-cisplatin in 1. Radiologic response to NAC was complete in 1 patient (8.3%), partial in 8 (66.7%) and stable disease in 3 (25.0%). Overall response rate was 75.0% (95% confidence interval, 51-100%). Grade 3 or 4 hematological toxicities were common, including neutropenia (50%) and anemia (8.3%), but were transient and manageable. Non-hematological toxicities were moderate and no treatment-related deaths were encountered. Eleven patients (91.7%) underwent complete surgical resection after induction. Surgical procedures comprised lobectomy in 10 patients, bilobectomy in 1 and pneumonectomy in 1. No severe intraoperative complications or 30-/90-day mortality were seen. At pathological evaluation, 8 patients (66.7%) showed downstaging of disease, with complete in 1 (8.3%), major in 3 (25.0%) and minor in 7 (58.3%). With a median follow-up of 12.7 months (range, 5.2-50.8 months), the 1-year relapse-free survival rate was 56.6%. Four of the 12 patients developed metastasis (at 4.7, 6.0, 8.4, and 9.2 months), and 2 patients died at 14.7 and 23.9 months.
Conclusion:
NAC using platinum-based chemotherapy with new-generation cytotoxic agents for locally advanced NSCLC seems justified by low morbidity and mortality, good response rates, and high resectability. Although the evidence level for induction chemotherapy is low, incorporation of chemotherapy and surgery will greatly impact strategies for future lung cancer treatment.
