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Short-course versus long-course neoadjuvant chemoradiotherapy in patients with rectal cancer: preliminary results of a randomized controlled trial

Radiation Oncology Journal 2020년 38권 2호 p.119 ~ 128
Aghili Mahdi, Khalili Nastaran, Khalili Neda, Babaei Mohammad, Farhan Farshid, Haddad Peiman, Salarvand Samaneh, Keshvari Amir, Fazeli Mohammad Sadegh, Mohammadi Negin, Ghalehtaki Reza,
소속 상세정보
 ( Aghili Mahdi ) - Tehran University of Medical Sciences Cancer Institute Radiation Oncology Research Center
 ( Khalili Nastaran ) - Tehran University of Medical Sciences School of medicine
 ( Khalili Neda ) - Tehran University of Medical Sciences School of medicine
 ( Babaei Mohammad ) - Tehran University of Medical Sciences Cancer Institute Radiation Oncology Research Center
 ( Farhan Farshid ) - Tehran University of Medical Sciences Cancer Institute Radiation Oncology Research Center
 ( Haddad Peiman ) - Tehran University of Medical Sciences Cancer Institute Radiation Oncology Research Center
 ( Salarvand Samaneh ) - Tehran University of Medical Sciences Cancer Institute Department of Anatomical and Clinical Pathology
 ( Keshvari Amir ) - Tehran University of Medical Sciences Imam Khomeini Hospital Complex Colorectal Research Center
 ( Fazeli Mohammad Sadegh ) - Tehran University of Medical Sciences Imam Khomeini Hospital Complex Colorectal Research Center
 ( Mohammadi Negin ) - Tehran University of Medical Sciences Cancer Institute Radiation Oncology Research Center
 ( Ghalehtaki Reza ) - Tehran University of Medical Sciences Cancer Institute Radiation Oncology Research Center

Abstract


Purpose: Colorectal cancer is becoming an increasing concern in the middle-aged population of Iran. This study aimed to compare the preliminary results of short-course and long-course neoadjuvant chemoradiotherapy treatment for rectal cancer patients.

Materials and Methods: In this clinical trial we recruited patients with rectal adenocarcinoma located from 5 cm to 15 cm above the anal verge. Patients in group I (short-course) received three-dimensional conformational radiotherapy with a dose of 25 Gy/5 fractions in 1 week plus concurrent XELOX regimen (capecitabine 625 mg/m2 from day 1?5 twice daily and oxaliplatin 50 mg/m2 on day 1 once daily). Patients in group II (long-course) received a total dose of 50?50.4 Gy/25?28 fractions for 5 to 5.5 weeks plus capecitabine 825 mg/m2 twice daily. Both groups underwent consolidation chemotherapy followed by delayed surgery at least 8 weeks after radiotherapy completion. The pathological response was assessed with tumor regression grade.

Results: In this preliminary report on complications and pathological response, 66 patients were randomized into two study groups. Mean duration of radiotherapy in groups I and II was 5 ± 1 days (range, 5 to 8 days) and 38 ± 6 days (range, 30 to 58 days). The median follow-up was 18 months. Pathological complete response was achieved in 32.3% and 23.1% of patients in the short-course and long-course groups, respectively (p = 0.558). Overall, acute grade 3 or higher treatment-related toxicities occurred in 24.2% and 22.2% of patients in group I and II, respectively (p = 0.551). No acute grade 4 or 5 adverse events were observed in either group except one grade 4 hematologic toxicity that was seen in group II. Within one month of surgery, no significant difference was seen regarding grade ≥3 postoperative complications (p = 0.333).

Conclusion: For patients with rectal cancer located at least 5 cm above the anal verge, short-course radiotherapy with concurrent and consolidation chemotherapy and delayed surgery is not different in terms of acute toxicity, postoperative morbidity, complete resection, and pathological response compared to long-course chemoradiotherapy.

키워드

Chemoradiotherapy; Clinical trial; Consolidation chemotherapy; Rectal Neoplasms; Dose hypofractionation; Iran

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