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M. Nicolosi
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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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P2.02-032 - Induction Histology-Based Combination Chemotherapy for Elderly Patients with Inoperable Non-Small Cell Lung Cancer (NSCLC) (ID 5178)
14:30 - 14:30 | Author(s): M. Nicolosi
- Abstract
Background:
SABR is an acceptable treatment of elderly patients with inoperable stage I-II NSCLC; for the stage III, sequential chemoradiotherapy may be appropriate, since it is better tolerated than concurrent chemoradiotherapy.
Methods:
In a prospective phase II not randomised study, patients aged 70 years or more with inoperable stage IIIA and IIIB histologically confirmed squamous cell carcinoma (SCC) or adenocarcinoma NSCLC and ECOG performance status (PS) 0-2, were treated with 3 cycles of induction chemotherapy according to their histology followed by definitive radiotherapy or possibile surgery in selected cases. Chemotherapy regimens included: carboplatin at AUC 5 i.v. plus gemcitabine 1000 mg/mq i.v. on days 1,8 or pemetrexed 500 mg/mq i.v. every 21 days in patients with squamous or adenocarcinoma, respectively. Primary endpoint was activity as defined by the overall response rates (ORR) following induction chemotherapy and overall survival (OS); secondary endpoints included feasibility outcome (i.e., toxicity, rate of definitive radioterapy, chemotherapy dose reduction or withdrawal) and progression-free survival (PFS).
Results:
Twenty-seven patients, 23 males, 4 females, with a median age of 74 years (range, 70-80), PS=0/1 in 9/15 (33/56%) or 2 in 3 (11%) and median of 2 (range, 0-5) active comorbidities requiring medical treatment were treated. Fourteen patients (52%) had an adenocarcinoma and were treated with carboplatin and pemetrexed, 13 a SCC (42%) with carboplatin and gemcitabine. Eight patients (30%) had a stage IIIA, 19 patients (70%) a stage IIIB. The median cycle of chemotherapy was 3 (range, 1-4). Dose reduction or withdrawal was required in 2 and 3 patients, respectively (18%). ORR was 46% (in 12 of 26 assessable patients); 5 patients with a SCC (42%) and 7 patients with an adenocarcinoma (50%). SD and PD were reported in 4 (15%) and 10 (38%) patients, respectively. Twelve patients (44%) were subsequently treated with radiotherapy, 8 (42%) with stage IIIB and 4 (50%) with stage IIIA. Two patients (7%) with stage IIIA disease underwent lobectomy. With a median follow-up of 10.2 months, 9 patients (33%) were alive and progression-free; median OS and PFS data will be shown. G1-G2 neutropenia, asthenia, anemia, nausea/vomiting and diarrhoea were the most frequent toxicity observed in ³ 10% of patients and up to 45% for neutropenia. G3-4 neutropenia, asthenia, thrombocytopenia and fever was reported in one patient each (4%), G3 anemia in 2 patients.
Conclusion:
In a broad elderly NSCLC population induction histology-based chemotherapy seems to be active and feasible in selected patients.
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P2.03a - Poster Session with Presenters Present (ID 464)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.03a-032 - Palliative Chemotherapy with Oral Metronomic Vinorelbine in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Unsuitable for Chemotherapy (ID 6214)
14:30 - 14:30 | Author(s): M. Nicolosi
- Abstract
Background:
Approximately one-third to one-half of all patients with advanced NSCLC presents with a disease that is unsuitable for conventional chemotherapy, both at the first or subsequent lines of treatment. This is mostly due to their very elderly age, poor performance status (PS), to the extent of the disease and/or comorbidities. The prognosis of this patients is extremely poor and no active treatment is often offered.
Methods:
In a prospective phase II not randomised study, patients with advanced stage IV histologically confirmed NSCLC who were deemed not eligible to standard chemotherapy because of elderly age (= or > 70 years), and/or poor ECOG PS (= or > 2), and/or extensive brain or bone disease, and/or active comorbidities (= or > 2) requiring pharmacological treatment, were treated with oral metronomic vinorelbine at the fixed dose of 30 mg three times a week until disease progression. Primary endpoint was feasibility, including toxicity and disease control rate (DCR=CR+PR+SD); secondary endpoints included duration of treatment, progression-free survival (PFS) and overall survival (OS) since the start of treatment.
Results:
37 patients, 29 males, 8 females, with a median age of 73 years (range, 50-86), PS=1/2/3 in 1/28/8 (3/76/22%), stage IVA/IVB in 11/26 (30/70%), brain/bone disease in 8/13 (22/35%) and a median of 3 (range, 0-5) active comorbidities were treated. Twenty-five patients had an adenocarcinoma (68%), 12 (32%) a squamous cell carcinoma; 2 patients had an active mutation of the EGFR gene and were previously treated with a TKI. Fourteen patients (38%) received the treatment as first line, 8 (22%) as second line, and 15 (41%) as third or subsequent line. The median cycle of chemotherapy administered was 2 (range, 1-8). G1/G2 toxicities were: asthenia in 20 (54%) patients, constipation in 13 (35%), nausea in 9 (26%), anemia in 5 (14%). G3 toxicities were: anemia in 2 (5%) patients, neutropenia and fatigue each in one patient (3%). None patient had G4 toxicity and required dose reduction. Out of the 36 assessable patients, DCR was 25% (in 9 patients). The median duration of treatment was 2.8 months (range, 0.3-8.4). With a median follow-up of 22.1 months, 3 patients (8%) are still alive; median OS was 5.5 months (range, 5.2-6.1) and median PFS 2.5 months (range, 2.4-2.8).
Conclusion:
In patients with very poor prognosis advanced NSCLC unsuitable for chemotherapy, oral metronomic vinorelbine may lead to a disease control in a quarter of patients with acceptable toxicities.
