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A.L. Ortega Granados
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MA06 - Locally Advanced NSCLC: Risk Groups, Biological Factors and Treatment Choices (ID 379)
- Event: WCLC 2016
- Type: Mini Oral Session
- Track: Locally Advanced NSCLC
- Presentations: 1
- Moderators:P. Van Houtte, M. Zemanová
- Coordinates: 12/05/2016, 16:00 - 17:30, Strauss 2
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MA06.09 - Efficacy RENO Study Results of Oral Vinorelbine or Etoposide with Cisplatin & Chemo-Radiation in Stage III NSCLC. SLCG 10/02 (ID 4238)
17:00 - 17:06 | Author(s): A.L. Ortega Granados
- Abstract
- Presentation
Background:
This study aims to compare efficacy and safety of two widely used combinations of cisplatin (P) in this setting: as etoposide (E) and vinorelbine. This last, in its oral formulation (oV) which has achieved comparable results as the IV formulation and patients (pts) prefer it.
Methods:
Pts between 18-75years, with histologically proven untreated and unresectable locally-advanced NSCLC (LA-NSCLC), adequate respiratory function, V20≤35% and ECOG-PS 0-1, were randomized 1:1 to oV-P arm: 2 induction cycles (cy) of oV-P followed by 2 cy more with RT; or to E-P arm: 2 cy of E-P concomitants to RT. Both arms with a total radiation dose of 66Gy administered 2 Gys daily. Primary endpoint was progression free survival (PFS) by RECIST 1.1. Secondary endpoints: overall response rate (ORR), overall survival (OS) and safety. With α-error of 0.05 (one-tailed test) and 0.1 β-error, median PFS unacceptable for the oV-P arm of 10 months (m) (p0) and a very acceptable of 15 m (p1), 122 eligible pts were required.
Results:
140 pts from 23 institutions of SLCG were randomized between 08/2011-12/2014. 134 pts were treated (66 in oV-P and 68 in E-P arms). Results based on this 134 pts are presented. Median age 62 years [39-76]; PS 0/1, 45%/55%; current smoker 51%; squamous cell 51%; stage IIIB 54%. 244 and 131 cy were given in the oV-P and E-P arms, respectively. All irradiated pts in oV-P arm received at least 60Gy, 7 pts in the E-P arm received less than 60Gy (4 due to toxicity). 1 pt (1.5%) in oV-P arm and 12 pts (17.6%) in E-P arm presented esophagitis G3/4 (p=0.002). 121 confirmed eligibility for efficacy analysis. ORR were 39 (64%) and 40 pts (67%) in the oV-P and E-P arms, respectively (p=0.889). After 16 m [1-43] of follow-up, 66% pts progressed and 43% pts died. Median PFS is 11.4 m (IC95%; 6-17) in oV-P arm and 11.8 m (IC95%; 7-16) in E-P arm (p=0.374).
Conclusion:
Both regimens achieve similar efficacy however oV-P has less toxicity, especially esophagitis G3/4. Further follow-up is needed for the survival analysis.
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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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P1.07-009 - Outcomes of Patients with Relapsed Small-Cell Lung Cancer Treated with Paclitaxel plus Gemcitabine. 10 Year-Analysis (ID 6403)
14:30 - 14:30 | Author(s): A.L. Ortega Granados
- Abstract
Background:
We conducted a retrospective study to investigate the outcome and prognostic factors of patients with relapsed SCLC who receive second or third line chemotherapy with paclitaxel plus gemcitabine, a regimen that is used in our institution since a phase II trial in 2001. We reviewed the medical records of patients with SCLC who received paclitaxel plus gemcitabine in a ten-years period, since 2005 from 2015. Overall survival (OS) from the initiation of this regimen was evaluated, plus characteristics of these patients.
Methods:
Patients diagnosed of SCLC were selected from our lung cancer database, and compared with our Pharmacy Department database. We selected all patients with relapsed SCLC that received therapy with paclitaxel plus gemcitabine (PG) at any moment of the disease.
Results:
Patient characteristics The median age of the cohort was 58 years (43–81 years). There were 69 males (83.2%) and 14 females (16.8%). 72 patients (86.7%) had a previous history of smoking. ECOG PS at relapse was 0 in 3 (3.6%), 1 in 70 (84.3%), and 2 in 10 (12.1%) patients. Fifty patients (60.2%) had extensive disease at baseline diagnosis, and the remaining 33 (38.8%) had limited disease. All patients were exposed previously to etoposide and platinum. The platinum used was cisplatin in 52 patients (60.3%) and carboplatin in 30 patients (38.7%). Previous radiation at local tumor site was received by 38 patients (45.8%). Response The response was evaluated in 78 patients. The response post‑2 months of PG was complete response in 2 patients (2.5%), partial response in 29 (37.1%), stable disease in 24 (30.7%), and progressive disease in 23 patients (30.6%). Toxicity The median number of cycles of PG received was 8 (2-28) cycles. Toxicity related cessation of treatment was required in 12 patients (14.4%). The reason for stoppage was Grade 3–4 toxicities in 8 patients (9.6%) and deterioration in PS in 4 patients (4.8%) Outcomes The median PFS was 148 days (95% CI: 30–173.5 days) while the median OS was 172 days (95% CI: 60–485 days).
Conclusion:
Paclitaxel plus gemcitabine it is a well tolerated regimen in relapsed SCLC in the schedule we usually use (every 2 weeks). Unless this study is retrospective, we believe that this combination can be used nowadays in these patients, if there is no clinical trial available.
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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-047 - Clinical Trial Participation and Outcomes in Non-Small Cell Lung Cancer: Case-Control Study (ID 6405)
14:30 - 14:30 | Author(s): A.L. Ortega Granados
- Abstract
Background:
There is some evidence that patients who participate in clinical trials have improved outcomes compared with patients receiving standard chemotherapy. We look forward if the outcome for patients with stage III and IV non-small cell lung cancer treated on a clinical trial was associated with a better outcome at our institution, a tertiary centre in Spain.
Methods:
Patients with NSCLC treated on standard chemotherapy/TKI between 2010 and 2015 were matched with individuals who received 1st line chemotherapy or TKI in a clinical trial in a ratio 2:1. Cases were matched for age (<65 years or >65 years), stage (III or IV), histology (adenocarcinoma, squamous), EGFR status (mutated vs wild-type) and therapy received in 1st line (platinum doublet, TKI). All patients were World Health Organisation (WHO) performance status 0 or 1.
Results:
Patients in each group were well matched for stage, histological sub type, surgery and treatment. The median follow up for patients treated on a trial was 3.2 years, compared with 2.8 years for matched patients who received standard 1st line therapy. The median overall survival for patients treated on a trial was 19.4 months, compared with 15.8 months for those in a matched control group. The difference between groups was not significant (Log rank test, HR 0.81, 95% CI: 0.42 to 1.35, p=0.5). The difference in overall survival between groups was not significant (Log Rank test, HR 0.87, 95%CI: 0.46 to1.64, p=0.7).
Conclusion:
Data from our institution, a tertiary centre active in clinical trials, shows a good outcome for patients with advanced NSCLC regardless of whether they received 1st line therapy on a clinical trial. There is a trend for a better outcome for those patients that are enrolled in a clinical trial, so this encourage our active participation in clinical research.
