ESTRO 2021 Abstract Book
evaluate the 1-year progression-free-survival (PFS) rate in the two arms. 36 pts were planned in the Mid-p arm, Fleming single-stage design (1-sided a=0.1, 80% power, P0=30%, P1=50%). Secondary objectives were to evaluate 1-y and 2-y LC, OS and acute/middle term toxicity (NCI-CTCAE v4). Results 54 pts were randomized from 09/12 to 05/18. 3 patients finally did not receive radiotherapy and were excluded from the analysis. Median age was 65.2 y, 2/3 of the patients were male and had IIIA NSCLC stages, 31% received concomitant chemotherapy. 34 pts and 17 pts were included in the analysis in the Mid-p arm and ITV arm respectively. Median RT dose was 66 Gy in the Mid-p arm and 62 Gy in the ITV arm. Median PFS were 9.3 months and 10.3 months in the Mid-p arm and ITV arms respectively. 1-year PFS rate were 38% (1-sided CI95% = [25-[) and 47% (CI95% = [27;[) in the Mid-p/ITV arm respectively. Efficacy in Mid-p arm is below that expected (starting hypothesis p0=30%, p1=50%). 2-year PFS rates were 15% (Mid-p) and 12% (ITV). 2-years LC rates were 65% (CI95% [48;81]) and 76% (CI95% [53;94]) in the Mid-p/ITV arms respectively (see Figure). The analysis of the type of local failures (in field versus border of fields) is under analysis and will be available for the congress. No grade 4 or toxic deaths related to RT were reported. Grade 3 acute lung toxicity were reported in 12% and 23% in Mid-p and in ITV arms respectively. Grade 2 and Grade 3 late radiation fibrosis were reported in 29% and 15% respectively in the Mid-p arm, versus 23% and 29% using ITV strategy.
Conclusion Two-year LC and PFS in LA-NSCLC seems similar in this non comparative Phase II randomized study using Mid-p or ITV strategies. The details of local relapses regarding RT fields and margins are under analysis and will be presented during the congress. PH-0272 Prospective quality of life in 682 lung cancer patients treated with radiotherapy: real life data M. Nies 1 , R. Wijsman 1 , O. Chouvalova 1 , F.J. Ubbels 1 , H.J. Elzinga 1 , E. Haan-Stijntjes 1 , M. Woltman-van Iersel 1 , A.H. van der Leest 1 , J.A. Langendijk 1 , A.G. Niezink 1 1 University Medical Center Groningen, Radiotherapy, Groningen, The Netherlands Purpose or Objective Although treatment options for lung cancer have improved, treatment outcome remains poor. The disease burden may interfere with patients’ well-being. Our objective was to prospectively evaluate lung cancer- specific quality of life (QoL) in patients with lung cancer treated with radiotherapy (RT). Materials and Methods At our department, all patients treated for lung cancer are included in a prospective data registration program. This program prospectively evaluates patient, tumor, treatment, and outcome characteristics at baseline, during RT, and at 3 months, 6 months, 1 year, and yearly thereafter. For the current study, we selected patients treated with (non-stereotactic) (chemo)radiotherapy (≥40 Gy) for (N)SCLC. QoL was evaluated using the radiotherapy-related questions of the lung cancer module of the EORTC Core lung cancer specific QoL Questionnaire (EORTC QLQ-LC13). The 4-point scale ranging from 1 (“not at all”) to 4 (“very much”) was dichotomized for the analyses. QoL scores upon baseline were compared with QoL scores upon the aforementioned follow-up time points. Results From 2013 to 2018, 692 patients were included in this program. Compliance for QoL assessments at baseline was 99%. At 12, 24, 48, and 60 months after RT, the compliance rates of eligible, surviving patients were 94%, 90%, 85, and 69%, respectively. Mean age at diagnosis was 67±10 SD years, 58% was male, and 16% had SCLC. WHO performance score was ≥2 in 16%. Most patients (69%) had stage III disease. The majority of patients received 60 Gy (75%) in 25 fractions (84%). Fifteen percent of patients received concurrent chemoradiotherapy, 61% received induction chemotherapy and concurrent chemoradiotherapy. At the end of RT, 24% of the patients reported moderate-to-severe swallowing problems, compared with 2% at baseline ( P <0.001). Additionally, 12% reported to have moderate-to-severe chest pains at the end of RT, compared with 4% at baseline ( P <0.001) (Figure 1). At 3 months of follow-up, these problems had recovered. At baseline, 16%, 9%, and 25% of patients reported problems with coughing, shortness of breath (SOB) when walking or SOB when climbing stairs, respectively. These percentages significantly increased to a maximum of 27%, 17%, and 38% and persisted significantly up to 2 years after treatment ( P <0.001, P <0.001,
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