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T.B. Nielsen
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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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P2.02-049 - Gender and Risk of Cessation of Oral Vinorelbine in a Randomized Trial of Concurrent Chemoradiation of Locally Advanced NSCLC (ID 5559)
14:30 - 14:30 | Author(s): T.B. Nielsen
- Abstract
Background:
Concurrent chemo-radiation (CRT) is the treatment of choice for local advanced NSCLC (LA-NSCLC) patients, but a number of patients do not full fill the course of chemotherapy, and this may decrease survival. The aim of this study is to evaluate the influence of gender on the risk of cessation of oral vinorelbine used as concurrent chemotherapy in a prospective clinical trial of chemoradiation of LA-NSCLC (The NARLAL trial). Data on esophagitis has previously been published demonstrating that females were more sensitive than males (Radiother.Oncol.2016;118:465).
Methods:
From 2009 to 2013, 117 patients with LA-NSCLC in performance status (PS) 0-1 entered a randomized phase II trial comparing 60 Gy with 66 Gy in 2 Gy fraction 5 days a week in 6 to 6.5 weeks concurrent with oral vinorelbine as fixed dose of 50 mg 3 times á week. The intended number of doses of vinorelbine was 17 to 19 depending on the treatment arm. In each of the treatment arms, 12% of the patients received 15 doses of oral vinorelbine or less; here designated as chemo-non-compliant.
Results:
In the NARLAL trial 49 female and 68 males participated. The median age were 65.5 years in both gender (p=ns), the distribution of stage did not differ significantly among gender, and neither did PS, but females had significant less pretreatment weight than males; the median being 70.0 and 84.0 kg, respectively. Altogether, 10 (20%) females and 4 (6%) males were chemo-non-compliant (p=0.04). The females had significant more grade esophagitis than men, and significant more women had a more than 5 pct. weight loss, 15 (31%) compared with 7 (10%) in men (P=.01). Chemo-non-compliance was associated with esophagitis grade 2 or more, and with weight loss ≥5%. In a logistic regression analysis of chemo-non-compliance only female and PS=1 was significant: Female OR=3.74 (95% CI 1. 07; 13.1), p=0.017; PS OR=5.59 (95% CI 1.70; 18.4), p=0.005), Introduction age, weight, body surface area (BSA), current smoking, or stage were non-significant factors.
Conclusion:
Females have a significant larger risk than males of not fulfilling chemotherapy with oral vinorelbine and to lose weight > 5% during concurrent chemo-radiation of LA-NSCLC. This cannot be explained by women having smaller BSA or weight than males.
