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- W2891293435 abstract "Abstract Background To observe the long-term outcomes of a phase I/II trial (NCT01843049) of simultaneous integrated boost (SIB) for dose escalation in unresectable thoracic esophageal cancer. Methods Patients with esophageal squamous cell carcinoma were treated with escalating radiation dose of 4 levels defined as our previous works (Yu et al. Radiother Oncol 2015). A prescription dose of 62.5–64Gy was delivered to the gross tumor volume, with (Level 3 & 4) or without (Level 1 & 2) a SIB up to 70 Gy for the pre-treatment 50% SUVmax area of the primary tumor. Patients also received 2 cycles of chemotherapy of cisplatin and fluorouracil concurrently and 2 more cycles after radiotherapy. Results Dose escalation has been safely achieved up to Level 4 with tolerable acute toxicities as previously reported, so a phase II trial was further performed basing on Level 4. After a median follow-up duration of 21.8 (2.5–61.4) months for all 34 patients and 40.1 (13.4–61.4) months for 17 patients still alive, median overall survival time was 42.4 months for all and 18.8/42.4/not achieved (median follow-up duration, 57.6 months)/10.8 months for Level 1/2/3/4 (n = 5/10/5/14), respectively. Median progression-free survival time was 11.7 months for all and 12.2/26.4/10.1/10.8 months for Level 1/2/3/4, respectively. Eight deaths occurred within the 20 patients in Level 1, 2 and 3, including 6 due to local or regional progression, 1 liver metastasis and 1 acute esophageal hemorrhage. Nine out of the 14 patients of Level 4 died, including 5 because of severe late esophageal toxicities (perforation, fistula or hemorrhage), 1 radiation-induced pericardial effusion, 1 brain metastasis, 1 local failure and 1 non-cancer-related heart disease. Conclusion Severe late esophageal toxicities might have compromised long-term survival after dose of Level 4 was delivered despite of tolerable acute toxicities. Dose escalation should be carried out in an appropriate dose-fractionation window, otherwise increased toxicities might conceal the potential benefit of tumor control brought by high dose intensity. Larger numbers of patients should be enrolled into Level 3 for further assessment of treatment tolerance. Disclosure All authors have declared no conflicts of interest." @default.
- W2891293435 created "2018-09-27" @default.
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- W2891293435 date "2018-09-01" @default.
- W2891293435 modified "2023-09-22" @default.
- W2891293435 title "PS02.033: SIMULTANEOUS INTEGRATED BOOSTING RADIATION DOSE IN UNRESECTABLE THORACIC ESOPHAGEAL CANCER: LONG-TERM OUTCOMES OF A PHASE I/II TRIAL" @default.
- W2891293435 doi "https://doi.org/10.1093/dote/doy089.ps02.033" @default.
- W2891293435 hasPublicationYear "2018" @default.
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