Acute Toxicity and Tumor Response in Locally Advanced Rectal Cancer After Preoperative Chemoradiation Therapy With Shortening of the Overall Treatment Time Using Intensity-Modulated Radiation Therapy With Simultaneous Integrated Boost: A Phase 2 Trial

But‐Hadžić, Jasna; Anderluh, Franc; Brecelj, Erik; Edhemović, Ibrahim; Secerov-Ermenc, A.; Hudej, R.; Jeromen, Ana; Koželj, Miran; Krebs, Bojan; Oblak, Irena; Omejc, Mirko; Vogrin, Andrej; Velenik, Vaneja

doi:10.1016/j.ijrobp.2016.08.031

Cited by 26 publications

(28 citation statements)

References 28 publications

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“…The interest of the SIB is that improves the dosimetry of the treatment plan, could shorten the treatment time and it could allow the reduction of the toxicity of the treatments. All these data on the SIB in the treatment of rectal cancer patients confirm the interest of this approach also in this clinical setting, as it has been already shown in other tumor sites (Lupattelli et al 2017 ; Franco et al 2014 , 2015 , 2016 , 2018 ; But-Hadzic et al 2016 ; De Rose et al 2018 ; Chatterjee et al 2019 ; Magli et al 2018 ).…”

Section: Discussionsupporting

confidence: 72%

Neoadjuvant chemoradiotherapy delivered with helical tomotherapy under daily image guidance for rectal cancer patients: efficacy and safety in a large, multi-institutional series

Bari

Franzetti-Pellanda

Saidi

et al. 2019

J Cancer Res Clin Oncol

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Purpose Helical tomotherapy (HT) has been recently introduced in the neoadjuvant treatment of locally advanced rectal cancer. Aim of this study is to report the toxicity and local control rates of a large series of locally advanced rectal cancer patients treated with neoadjuvant chemotherapy and HT under daily image guidance followed by surgery. Methods Data from 117 locally advanced rectal cancer patients treated at two Swiss Radiotherapy departments were collected and analyzed. Radiotherapy consisted of 45 Gy (1.8 Gy/fraction, 5 fractions/week delivered in 5 weeks) to the regional pelvic lymph nodes. Seventy patients also received a simultaneous integrated boost (SIB) up to 50 Gy to the tumor and involved nodes (2 Gy/fraction, 5 fractions/week delivered in 5 weeks). Chemotherapy consisted of capecitabine 825 mg/m 2 , twice daily, during the irradiation days. After a median interval of 59 days [95% confidence interval (CI) 53–65 days), all patients underwent surgery. Results Median follow-up was 45 months (range 4–90 months). The overall rate of acute grade 2–4 toxicity was 18.8% ( n = 22). Four patients (3.4%) presented a grade 3 dermatitis ( n = 1) or diarrhea ( n = 3), and 1 (0.8%) demonstrated grade 4 rectal toxicity. No patients presented with grade ≥ 3 hematologic toxicity. Six patients (5.1%) had late grade 3 gastrointestinal toxicity. The 4-year local control rate was 88.4% (95% CI 87.5–88.5%). Conclusions Neoadjuvant chemoradiotherapy delivered with HT under daily image guidance is well tolerated and shows a high 4-year local control rates.

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Section: Discussionsupporting

confidence: 72%

Neoadjuvant chemoradiotherapy delivered with helical tomotherapy under daily image guidance for rectal cancer patients: efficacy and safety in a large, multi-institutional series

Bari

Franzetti-Pellanda

Saidi

et al. 2019

J Cancer Res Clin Oncol

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“…Between January 2014 and November 2015, a total of 51 patients were treated ( Figure 2 ). Patients and tumour characteristics were described in detail elsewhere 16 , but, briefly – the median age of the group was 66 years (range, 30–81 years) and two thirds were men. Nearly half of the tumours were located in the lower third of the rectum and 20 patients had positive mesorectal fascia (MRF+).…”

Section: Resultsmentioning

confidence: 99%

“…The trial design, eligibility criteria, and treatment details have been published previously in detail. 16 In brief, patients had to present with histologically confirmed, operable adenocarcinoma, located within 15 cm from the anal verge. Patients with locally advanced, non-metastatic disease (cT ≥ 3 and/or cN ≥ 1 on magnetic resonance imaging (MRI) and M0 on CT thorax/abdomen) without contraindications for chemotherapy were included.…”

Section: Methodsmentioning

confidence: 99%

“…PTV 1 received 41.8 Gy in 22 fractions and SIB was prescribed to tumour (PTV 2) concomitantly to doses of 46.2 Gy and 48.4 Gy to T ≤ 3 and T4 tumours in 22 fractions, respectively, 5 times per week (Monday to Friday) ( Table 1 ). The main constraints for organs at risk were: V 45Gy < 195 cc and D max ≤ 50 Gy; anal canal V 40Gy ≤ 40% and D max ≤ 55 Gy; iliac crests V 30Gy < 50 %, V 40Gy < 35%; bladder V 30Gy < 50% and V 35Gy < 35%; and penile bulb D 90% < 50 Gy 16 ( Figure 1 ).…”

Section: Methodsmentioning

confidence: 99%

“…In recently published early results from our trial, we demonstrated that preoperative radiochemotherapy with IMRT-SIB without dose escalation, concomitantly with capecitabine, can achieve a high rate of pCR, a downstaging with a very low acute toxicity profile, and excellent compliance. 16 After the 2-year follow-up, we analysed the impact of experimental fractionation on LC, disease-free survival (DFS), and overall survival (OS).…”

Section: Introductionmentioning

confidence: 99%

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Preoperative intensity-modulated chemoradiation therapy with simultaneous integrated boost in rectal cancer: 2-year follow-up results of phase II study

But‐Hadžić

Velenik

2018

Radiology and Oncology

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BackgroundThe aim of the study was to investigate the feasibility and safety of experimental fractionation using intensity modulated radiation therapy with a simultaneous integrated boost (IMRT-SIB) to shorten the overall treatment time without dose escalation in preoperative radiochemotherapy of locally advanced rectal cancer.Patients and methodsBetween January 2014 and November 2015, a total of 51 patients with operable stage II-III rectal adenocarcinoma were treated. The preoperative treatment with intensity modulated radiation therapy (IMRT) and a pelvic dose of 41.8 Gy and simultaneously delivered 46.2 Gy to T2/3 and 48.4 Gy to T4 tumour in 22 fractions, with standard concomitant capecitabine, was completed in 50 patients out of whom 47 were operated. The median follow-up was 35 months.ResultsThe rate of acute toxicity G ≥ 3 was 2.4%. The total downstaging rate was 89% and radical resection was achieved in 98% of patients. Pathologic complete response (pCR) was observed in 25.5% of patients, with 2-year local control (LC), disease free survival (DFS), and overall survival (OS) of 100% for this patient group. An intention-to-treat analysis revealed pN to be a significant prognostic factor for DFS and OS (P = 0.005 and 0.030, respectively). LC for the entire group was 100%, and 2-year DFS and OS were 90% (95 % CI 98.4–81.6) and 92.2% (95% CI 99.6–84.7), respectively.ConclusionsThe experimental regime in this study resulted in a high rate of pCR with a low acute toxicity profile. Excellent early results translated into encouraging 2-year LC, DFS, and OS.

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Radiothérapie avec modulation d’intensité préopératoire des cancers rectaux : intérêt et application

Randrian

Biau

Benoît

et al. 2020

Cancer/Radiothérapie

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Acute Toxicity and Tumor Response in Locally Advanced Rectal Cancer After Preoperative Chemoradiation Therapy With Shortening of the Overall Treatment Time Using Intensity-Modulated Radiation Therapy With Simultaneous Integrated Boost: A Phase 2 Trial

Cited by 26 publications

References 28 publications

Neoadjuvant chemoradiotherapy delivered with helical tomotherapy under daily image guidance for rectal cancer patients: efficacy and safety in a large, multi-institutional series

Neoadjuvant chemoradiotherapy delivered with helical tomotherapy under daily image guidance for rectal cancer patients: efficacy and safety in a large, multi-institutional series

Preoperative intensity-modulated chemoradiation therapy with simultaneous integrated boost in rectal cancer: 2-year follow-up results of phase II study

Radiothérapie avec modulation d’intensité préopératoire des cancers rectaux : intérêt et application

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