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A. Khalil
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OA24 - Radiotherapy of Lung Cancer: Recent Developments (ID 411)
- Event: WCLC 2016
- Type: Oral Session
- Track: Radiotherapy
- Presentations: 1
- Moderators:K. Dieckmann, S. Rieken
- Coordinates: 12/07/2016, 14:20 - 15:50, Stolz 1
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OA24.05 - The Nordic HILUS-Trial - First Report of a Phase II Trial of SBRT of Centrally Located Lung Tumors (ID 6140)
15:05 - 15:15 | Author(s): A. Khalil
- Abstract
- Presentation
Background:
Early attempts of stereotactic body radiation therapy (SBRT) of centrally located lung tumors resulted in high toxicity, questioning the utility of the method in this situation. Since then, different risk adapted fractionation schedules with acceptable toxic effects have been reported from various institutions. However, consensus on the tolerability of centrally located structures to high-fraction doses is still lacking and the clinical toxic effects in relation to dose to organs at risk (OAR) need to be evaluated.
Methods:
We here report a first toxicity analysis of the HILUS-trial – a prospective Nordic multicenter non-randomized phase II trial of SBRT to centrally located lung tumors. Patients with a centrally located tumor (defined as ≤1cm from the proximal bronchial tree) from either a primary non-small cell lung cancer (NSCLC) or a progressive metastasis from another solid tumor were eligible for the trial. Maximum tumor diameter was 5 cm. Patients receiving concomitant systemic anticancer therapy or with tumors reaching through the wall of a main bronchus were not eligible. All the patients were treated with 7Gyx8 and stratified to either arm A (=tumors close to a main bronchus) or arm B (=tumors close to a lobar bronchus). The aim was to include 30 patients in each arm. Follow-up was conducted every 3[rd] month during the first 2 years and thereafter every 6[th] month. The trial was approved by ethical committees in each country.
Results:
Seventy-four patients (42 in arm A and 31 in arm B) were included between 2011 and 2016. Sixty-five patients experienced side effects from the study treatment; the most common being grade 1-2 dyspnea, grade 1-2 cough and grade 1-2 fatigue. Twenty-one patients (28%) experienced grade 3-5 side effects (atrioventricular block, bleeding, dyspnea, empyema, fatigue, fever, fistula, lung infection, pain, pneumonitis, pneumothorax and ventricular arrhythmia). Seven patients (6 in group A and 1 in group B) may have suffered grade 5 side effects; six patients experienced lethal hemoptysis after a median of 15.5 months (2.5-21months) and one patient suffered from a lethal pneumonitis 5 months post study treatment. Grade 4-5 side effects occurred more frequently in group A than in group B (19% vs 3%). Further analyses of risk factors for serious toxicity in relation to dose-volume parameters and patient- and tumor characteristics will be presented.
Conclusion:
SBRT of centrally located tumors may be afflicted with high risk of serious toxicity and further evaluation of clinical and dose-volume dependent risk factors are highly warranted.
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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): A. Khalil
- 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.
