Surgical timing after chemoradiotherapy for rectal cancer, analysis of technique (STARRCAT): results of a feasibility multi-centre randomized controlled trial

Foster, Jake; Ewings, Paul; Falk, Stephen; Roach, Huw; West, Nicholas P.; Williams-Yesson, Barbara; Hanna, George B.; Francis, Nader; Investigators, Starrcat

doi:10.1007/s10151-016-1514-7

Cited by 20 publications

(23 citation statements)

References 27 publications

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“…). A total of 26 publications, including four RCTs and 25 445 patients with rectal cancer were eligible for inclusion ( Table ). Twenty‐four of the 26 studies (22 650 patients) reported the primary endpoint of pCR based on the predefined wait interval and were included in the qualitative and quantitative analysis for this outcome variable; 15·9 per cent (1522 of 9551) and 11·3 per cent (1481 of 13 099) had achieved pCR in the extended and classical intervals respectively.…”

Section: Resultsmentioning

confidence: 99%

“…All patients underwent neoadjuvant 5FU‐based (5FU–capecitabine–folinic acid) nCRT, except in seven trials that included some patients treated with concomitant oxaliplatin (5 trials) or irinotecan (2) in addition to 5FU or had a proportion of patients who had nSCRT (1 trial). The number of participants in the included trials ranged from 31 to 16 915; apart from the RCTs and one phase II non‐randomized trial, all were retrospective or prospective observational series. Median follow‐up ranged from 14·25 months to 5 years.…”

Section: Resultsmentioning

confidence: 99%

“…Thirty-day mortality and local recurrence, distant metastasis, RFS and overall survival (OS) rates were also evaluated. Stein et al 21 Tran et al 22 Tulchinsky et al 23 De Campos-Lobato et al 24 Evans et al 32 Garcia-Aguilar et al 31 Wolthuis et al 25 Saglam et al 33 Jeong et al 43 You et al 44 Zeng et al 46 Sirohi et al 45 Probst et al 47 Mihmanlı et al 49 Timudom et al 48 Akbar et al 26 Lefevre et al 35 Kwak et al 51 Foster et al 34 Garrer et al 50 Lee et al 52 Kuan et al 53 Akgun et al 36 Kim et al 54…”

Section: Secondary Outcomesmentioning

confidence: 99%

“…Since then, a number of studies, including four RCTs, have been published; only two of the RCTs had pCR as a primary endpoint. GRECCAR‐6 compared intervals of 11 and 7 weeks and found no significant difference in pCR rates; however, a significant increase in morbidity and decrease in TME quality was observed in patients who had an 11‐week interval.…”

Section: Introductionmentioning

confidence: 99%

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Meta-analysis of the effect of extending the interval after long-course chemoradiotherapy before surgery in locally advanced rectal cancer

Ryan

O’Sullivan

Kelly

et al. 2019

British Journal of Surgery

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Background The current standard of care in locally advanced rectal cancer (LARC) is neoadjuvant long‐course chemoradiotherapy (nCRT) followed by total mesorectal excision (TME). Surgery is conventionally performed approximately 6–8 weeks after nCRT. This study aimed to determine the effect on outcomes of extending this interval. Methods A systematic search was performed for studies reporting oncological results that compared the classical interval (less than 8 weeks) from the end of nCRT to TME with a minimum 8‐week interval in patients with LARC. The primary endpoint was the rate of pathological complete response (pCR). Secondary endpoints were recurrence‐free survival, local recurrence and distant metastasis rates, R0 resection rates, completeness of TME, margin positivity, sphincter preservation, stoma formation, anastomotic leak and other complications. A meta‐analysis was performed using the Mantel–Haenszel method. Results Twenty‐six publications, including four RCTs, with 25 445 patients were identified. A minimum 8‐week interval was associated with increased odds of pCR (odds ratio (OR) 1·41, 95 per cent c.i. 1·30 to 1·52; P < 0·001) and tumour downstaging (OR 1·18, 1·05 to 1·32; P = 0·004). R0 resection rates, TME completeness, lymph node yield, sphincter preservation, stoma formation and complication rates were similar between the two groups. The increased rate of pCR translated to reduced distant metastasis (OR 0·71, 0·54 to 0·93; P = 0·01) and overall recurrence (OR 0·76, 0·58 to 0·98; P = 0·04), but not local recurrence (OR 0·83, 0·49 to 1·42; P = 0·50). Conclusion A minimum 8‐week interval from the end of nCRT to TME increases pCR and downstaging rates, and improves recurrence‐free survival without compromising surgical morbidity.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Secondary Outcomesmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Meta-analysis of the effect of extending the interval after long-course chemoradiotherapy before surgery in locally advanced rectal cancer

Ryan

O’Sullivan

Kelly

et al. 2019

British Journal of Surgery

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“…DNA damage may occur immediately with neoadjuvant chemotherapy (nCRT), however, cellular lysis only occurs in the weeks after irradiation, and regression is time dependent. In our study, we highlighted that the analysis was limited by the inclusion of only four RCTs and that subgroup analysis of RCTs exclusively did not demonstrate an enhanced pathological complete response (pCR) rate with the increased interval (odds ratio (OR) 1·15, 95 per cent c.i. 0·65 to 2·04; P = 0·63).…”

mentioning

confidence: 87%

Author response to: Should a minimum 8-week interval between preoperative radiotherapy and surgery become the standard of care? No, it shouldn't

Ryan

O’Riordan

Winter

2020

British Journal of Surgery

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Association of Surgical Skill Assessment With Clinical Outcomes in Cancer Surgery

et al. 2020

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IMPORTANCE Complex surgical interventions are inherently prone to variation yet they are not objectively measured. The reasons for outcome differences following cancer surgery are unclear.OBJECTIVE To quantify surgical skill within advanced laparoscopic procedures and its association with histopathological and clinical outcomes. DESIGN, SETTING, AND PARTICIPANTSThis analysis of data and video from the Australasian Laparoscopic Cancer of Rectum (ALaCaRT) and 2-dimensional/3-dimensional (2D3D) multicenter randomized laparoscopic total mesorectal excision trials, which were conducted at 28 centers in Australia, the United Kingdom, and New Zealand, was performed from 2018 to 2019 and included 176 patients with clinical T1 to T3 rectal adenocarcinoma 15 cm or less from the anal verge. Case videos underwent blinded objective analysis using a bespoke performance assessment tool developed with a 62-international expert Delphi exercise and workshop, interview, and pilot phases.INTERVENTIONS Laparoscopic total mesorectal excision undertaken with curative intent by 34 credentialed surgeons.MAIN OUTCOMES AND MEASURES Histopathological (plane of mesorectal dissection, ALaCaRT composite end point success [mesorectal fascial plane, circumferential margin, Ն1 mm; distal margin, Ն1 mm]) and 30-day morbidity. End points were analyzed using surgeon quartiles defined by tool scores. RESULTSThe laparoscopic total mesorectal excision performance tool was produced and shown to be reliable and valid for the specialist level (intraclass correlation coefficient, 0.889; 95% CI, 0.832-0.926; P< .001). A substantial variation in tool scores was recorded (range, 25-48). Scores were associated with the number of intraoperative errors, plane of mesorectal dissection, and short-term patient morbidity, including the number and severity of complications. Upper quartile-scoring surgeons obtained excellent results compared with the lower quartile (mesorectal fascial plane: 93% vs 59%; number needed to treat [NNT], 2.9, P = .002; ALaCaRT end point success, 83% vs 58%; NNT, 4; P = .03; 30-day morbidity, 23% vs 50%; NNT, 3.7; P = .03). CONCLUSIONS AND RELEVANCEIntraoperative surgical skill can be objectively and reliably measured in complex cancer interventions. Substantial variation in technical performance among credentialed surgeons is seen and significantly associated with clinical and pathological outcomes.

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Surgical timing after chemoradiotherapy for rectal cancer, analysis of technique (STARRCAT): results of a feasibility multi-centre randomized controlled trial

Abstract: Background and Objectives: The optimal time of rectal resection after long-course

Cited by 20 publications

References 27 publications

Meta-analysis of the effect of extending the interval after long-course chemoradiotherapy before surgery in locally advanced rectal cancer

Meta-analysis of the effect of extending the interval after long-course chemoradiotherapy before surgery in locally advanced rectal cancer

Author response to: Should a minimum 8-week interval between preoperative radiotherapy and surgery become the standard of care? No, it shouldn't

Association of Surgical Skill Assessment With Clinical Outcomes in Cancer Surgery

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