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I. Walraven



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    ORAL 20 - Chemoradiotherapy (ID 124)

    • Event: WCLC 2015
    • Type: Oral Session
    • Track: Treatment of Locoregional Disease – NSCLC
    • Presentations: 1
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      ORAL20.03 - Radiation Dose Escalation in Patients with Locally Advanced Non-Small Cell Lung Cancer; 60 Month Follow-Up of a Randomized Phase II Trial (ID 1190)

      11:07 - 11:18  |  Author(s): I. Walraven

      • Abstract
      • Presentation
      • Slides

      Background:
      Concurrent chemoradiotherapy imposes beneficial effects on overall survival (OS) in patients with locally advanced non-small cell lung cancer (NSCLC). Nonetheless, the optimal radiation scheme still needs to be identified. The RTOG 0617 trial showed that patients receiving a high dose radiation scheme (37 x 2 Gy) had a significant shorter median OS (22.9 months) as compared to patients receiving a conventional 30 x 2 Gy radiation scheme (28.7 months). Dose escalation using hypo-fractionation however seems promising and might contribute to a better OS. We investigated long term OS in locally advanced NSCLC patients treated with concurrent chemoradiotherapy, using a hypo-fractionation scheme of 24 x 2.75 Gy +/- Cetuximab.

      Methods:
      A 2-armed phase II, multi-center study (NTR2230) was performed with the initial aim to assess the effect of the addition of Cetuximab to concurrent chemoradiotherapy in locally advanced NSCLC patients. Arm A received high dose radiotherapy (24 x 2.75 Gy) and concurrent daily low-dose cisplatin (6 mg/m[2]). Arm B received an identical treatment regimen with the addition of weekly Cetuximab (400 mg/m[2] loading dose one week prior to radiotherapy followed by weekly 250 mg/m[2]). Mortality follow-up information was completed until January 2015. Overall survival (OS) rates were calculated as time from randomization until death from any cause. Kaplan-Meier survival curves were plotted and 1-, 2- and 5-year OS proportions were calculated.

      Results:
      Between February 2009 and May 2011, 102 patients were randomly allocated in two arms; 51 patients (50%) in arm A and 51 patients (50%) in arm B. Follow-up information was available for 101 patients (99%). Median OS was 33.0 months (interquartile (IQ) range 20.0 to 46.0) and did not significantly differ between the two arms; 33.0 months (IQ-range 13.8 to 52.2) in Arm A and 30.0 months (IQ-range 15.3 to 44.7) in Arm B (Figure 1). 1-,2- and 5-year OS was 75.5%, 59.8% and 36.6%, respectively. Figure 1



      Conclusion:
      In this 2-armed phase II trial in NSCLC patients receiving concurrent chemoradiotherapy, the addition of Cetuximab to concurrent chemoradiotherapy did not improve 60-month OS in unselected patients with locally advanced NSCLC, in line with the RTOG 0617. However, the median OS was remarkably high when compared to the RTOG 0617: 30 and 33 months versus 23 and 29 months, respectively. Furthermore, 5-year OS was still 36.6%. Dose escalation using hypo-fractionation of 2.75 Gy per fraction might be one of the factors contributing to extended OS in patients with locally advanced NSCLC.

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    P1.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 206)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      P1.01-029 - Dutch Radiotherapy Lung Audit: Results of 2014 (ID 1340)

      09:30 - 09:30  |  Author(s): I. Walraven

      • Abstract
      • Slides

      Background:
      The Dutch Radiotherapy Lung Audit (DLRA) is an outcome registration that provides the local health professionals with an instrument to compare and improve their lung cancer treatments. It ensures transparency regarding clinical outcome, quality and safety of lung cancer treatments in the radiotherapy departments throughout the Netherlands. Patients receiving thoracic radiation treatment with curative intent for (primary or recurrent) stage I-IIIB Non-Small Cell Lung Cancer (NSCLC) were included in the registry. The results of the DLRA on the first fully registered year, 2014, are reported.

      Methods:
      Information collected included patient, tumor and treatment characteristics, the incidence and severity of acute toxicity, mortality within three months after radical radiation treatment and the time interval between diagnostic work-up and start of the radiotherapy. The adherence to the waiting time (time between referral and start of the irradiation) and throughput time (time between planning CT scan and start of the irradiation) guidelines were registered and analyzed, as well as the use of modern treatment techniques such as stereotactic irradiation and image-guided radiotherapy.

      Results:
      14 out of 21 radiotherapy institutes included patients in the DLRA database. A total of 1350 patients were entered from January-December 2014. Patients were treated with concurrent (32%) or sequential chemoradiation(20%), radiotherapy only (13%) or stereotactic ablative body radiotherapy (SABR [35%]). On a patient record level, there was a high level of completeness. The mean age was 69 years (range 32-91, 59% males). Charlson comorbidity index ≥ 2 was present in 42% of patients. Most patients (45%) were cN+ with 20% cT4 tumors. Fifty eight percent of all patients started irradiation within 21 days after referral (range 0-89%). For 68% of the patients SABR started within 10 days after the planning-CT scan was acquired (range 17-100%) (fig 1). There was no correlation between the number of patients treated and the throughput times. Most patients received IMRT or VMAT irradiation. All registered patients had position verification during irradiation, mostly 3D (94%). Three-month (calculated from the end of RT) acute esophagus toxicity (grade≥ III) and pneumonitis (grade≥ II) of concurrent treatment were 12.4% and 3.9%, 6.1% and 4.1% for sequential chemoradiation, 3.3% and 4.3% for radiotherapy only, and 0.4% and 2.3% for SABR, respectively. Three-month mortality rates were 8.2%, 8.5%, 9.6%, and 1.7%, respectively. Figure 1



      Conclusion:
      The Dutch Radiotherapy Lung Audit on outcomes after (chemo)radiotherapy is directed towards an improvement of care for lung cancer patients. There's room for improvement in the waiting and throughput times.

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    P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      P2.01-051 - Determinants of Sequential versus Concurrent Chemoradiotherapy in Stage III Non-Small Cell Lung Cancer Patients (ID 1205)

      09:30 - 09:30  |  Author(s): I. Walraven

      • Abstract
      • Slides

      Background:
      Concurrent chemoradiotherapy (CCRT) is considered the standard treatment regimen in patients with inoperable stage III non-small cell lung cancer (NSCLC). Sequential chemoradiotherapy (SCRT) is recommended in patients who are deemed unfit to receive CCRT. As this selection criterion is not very explicit, the ‘personalized’ choice for either CCRT or SCRT is mainly dependent on the multidisciplinary team and treating physician’s judgment. Consequently, this may result in a variation of treatment policies across hospitals/radiotherapy (RT) departments. In this study, we investigated the ratio CCRT/SCRT in eight RT departments in the Netherlands. Furthermore, we explored which patient and disease characteristics determined the choice for SCRT compared to CCRT.

      Methods:
      Data were derived from the Dutch Lung Radiotherapy Audit (DLRA). Within the DLRA, lung cancer patients undergoing a curative intent treatment are prospectively registered with respect to patient and disease characteristics, diagnostics and treatment. For this study, from eight out of 21 Dutch RT departments, patients with stage III NSCLC undergoing chemoradiotherapy in 2014 were selected. CCRT was defined as ≤ 50 days between the start of chemotherapy and the start of radiotherapy. Furthermore, RT had to start before the end of the last chemotherapy in CCRT. Patients with < 150 days between treatments were scored as undergoing SCRT. Differences in patient and disease characteristics between CCRT and SCRT were tested with independent samples t-tests (for continuous variables) and with chi-square tests (for categorical variables). A multivariate logistic regression model was constructed to determine patient and disease characteristics associated with the choice for SCRT, using a backward selection procedure. Odds ratios (OR) with 95% confidence intervals (CI) are reported.

      Results:
      In total, 453 stage III NSCLC patients (mean age 65.4 years, 56.5% male) were registered. Of those, 351 (77.5%) patients underwent CCRT and 102 (22.5%) patients received SCRT. The proportion of patients treated with CCRT ranged from 51% to 89% across RT departments. Gender, smoking, gross target volume (GTV), performance score (PS), lung function, Charlson comorbidity index and tumor location were not significantly associated with SCRT in the multivariate model. Conversely, older age (OR 1.05 [95%CI 1.03-1.09]), histology (large cell carcinoma vs adenocarcinoma [OR 0.42 CI 0.19 to 0.97]) and cN-stage (N3 vs N0-1 [OR 5.71 {95%CI 2.10-15.50}]) were significantly associated with SCRT.

      Conclusion:
      In this selected group of registered NSCLC patients, a large variation was observed in the proportion of stage III NSCLC patients treated with CCRT, ranging from 51% to 89% across RT departments. Surprisingly, PS and comorbidity index (as indicators of a patients’ physical fitness) were not significantly different in CCRT or SCRT patients while age and cN-stage were. Based on the analyzed patient and disease characteristics, it is currently unclear why patients treated with SCRT were not eligible for CCRT.

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