A clinical trial to evaluate the worth of preoperative multimodality therapy in patients with operable carcinoma of the rectum

Hyams, David M.; Mamounas, Eleftherios P.; Petrelli, Nicholas J.; Rockette, Howard E.; Jones, Judy; Wieand, Harry S.; Deutsch, Melvin; Wickerham, D. Lawrence; Fisher, Bernard; Wolmark, Norman

doi:10.1007/bf02054976

Cited by 347 publications

(146 citation statements)

References 26 publications

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“…We found that patients with pCR had better disease-specific survival than those with either post-treatment stage I or stage IIA disease. Our data is consistent with the previous findings from other carcinoma sites that pCR is associated with better prognosis [24][25][26][27][28][29]. Given the rarity and the limited number of patients with PDA who received neoadjvant CRT had pCR in pancreatectomy reported in this study, future collaborative studies of a larger patient population is needed to confirm the prognostic values of pCR in patients with PDA.…”

Section: Discussionsupporting

confidence: 92%

“…The extent of residual invasive adenocarcinoma in post-therapy specimens has been shown to correlate with the prognosis in patients with several types of carcinomas, including PDA, esophageal cancer, and rectal cancer [24][25][26][27][28][29]. In our previous study of 240 patients with PDA who received neoadjuvant CRT and pancreaticoduodenectomy, we showed that posttherapy tumor stage (ypT), lymph node status (ypN), and the post therapy AJCC pathologic stage were independent prognostic factors of both disease-free and overall survivals in this group of patients [30].…”

Section: Discussionmentioning

confidence: 99%

“…In other tumor sites, patients who achieved pCR after neoadjuvant therapy have better prognosis. Patients with pCR in rectal specimens who received neoadjuvant chemoradiation have better disease-free and overall survival than patients with residual rectal adenocarcinoma [24][25][26][27][28][29]. Similarly, patients with pCR in esophagectomy specimens after neoadjuvant therapy also had better prognosis than those with residual disease [12,14].…”

Section: Discussionmentioning

confidence: 99%

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Pathologic complete response to neoadjuvant therapy in patients with pancreatic ductal adenocarcinoma is associated with better prognosis

Wang¹,

Zhao²

2012

Annals of Diagnostic Pathology

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In patients with pancreatic ductal adenocarcinoma (PDA) who received neoadjuvant therapy and pancreatectomy, pathologic complete response (pCR) is rarely observed and the prognostic significance of pCR is not clear. In this study, we reported 11 patients with pCR (2.5%) from 442 patients with PDA who received neoadjuvant treatment and pancreatectomy from 1995 to 2010. There were 6 men and 5 women with median age of 61 years. Four patients had either synchronous or prior history of extra-pancreatic cancer. Five patients received neoadjuvant chemotherapy followed by chemoradiation, and 6 received chemoradiation alone. Ten patients had pancreaticoduodenectomy and one had distal pancreatectomy. Scar and chronic pancreatitis consistent with therapy effect were present in all cases (100%). Pancreatic intraepithelial neoplasia 3 (Pan IN3)/carcinoma in situ was present in 5 cases, PanIN1 and PanIN2 in 5 cases. However, no residual invasive carcinoma or lymph node metastasis was identified in all cases. Follow-up information was available in 10 patients. Follow-up time ranges from 6 to 194 months (median, 63 months). During follow-up, three patients died of other causes and one developed a second primary PDA in the tail of pancreas at 84 months after initial pancreaticoduodenectomy and died at 105 months after the initial diagnosis of PDA. The other 6 patients were alive with no evidence of disease. Patients with pCR had better survival than those who had post-therapy stage I or IIA

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Section: Discussionsupporting

confidence: 92%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Pathologic complete response to neoadjuvant therapy in patients with pancreatic ductal adenocarcinoma is associated with better prognosis

Wang¹,

Zhao²

2012

Annals of Diagnostic Pathology

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“…Several phase II studies of 5-fluorouracil-based preoperative chemoradiotherapy for locally advanced rectal cancer have reported R0 resection rates of 60 -85% (Chan et al, 1993;Minsky et al, 1993;Keilholz et al, 1995;Videtic et al, 1998;Küchenmeister et al, 2000;Rödel et al, 2000) including pathologic complete response (pCR) rates of 5 -20%. Even in low rectal tumours, sphincter-preserving surgery was possible after preoperative chemoradiotherapy in 27 -86% of the patients (Grann et al, 1997;Hyams et al, 1997;Maghfoor et al, 1997;Küchenmeister et al, 2000). Moreover, randomised trials have shown that neoadjuvant chemoradiotherapy improves local control compared with postoperative chemoradiation in primary resectable tumours (Roh et al, 2001;Sauer et al, 2004).…”

mentioning

confidence: 99%

Intensified concurrent chemoradiotherapy with 5-fluorouracil and irinotecan as neoadjuvant treatment in patients with locally advanced rectal cancer

Klautke¹,

Feyerherd

Ludwig

et al. 2005

Br J Cancer

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This study aimed to evaluate the feasibility and efficacy of neoadjuvant chemoradiotherapy intensified with irinotecan in patients with locally advanced rectal cancer. Eligible patients had nonmetastatic disease at a locally advanced stage that made R0 resection and sphincter preservation uncertain. They received preoperative radiation over 6 weeks to 45 Gy and boost of 5.4 Gy and concurrent continuous infusion 5-fluorouracil 250 mg m À2 day À1 and weekly irinotecan 40 mg m À2 . In all, 37 patients entered the study. T stage at baseline as determined by ultrasound was T2/T3/T4 in 2/19/16 patients; 31 patients had lymph node involvement. The predominant toxicity was diarrhoea (grade 3/4 in 10/2 patients). Haematologic toxicity and surgical complications were moderate. Among 36 patients undergoing surgery, 32 (89%) had R0 resection and 23 (64%) sphincter preservation. Pathologic complete response (pCR) was achieved in eight (22%) of 36 patients, and 10 patients (28%) had only microscopic residual disease. At 4 years, overall survival was 66%, disease-free survival 73%, local relapse rate 7%, and distant failure rate 24%. Extent of resection and postoperative nodal status were significant predictors of overall and disease-free survival. Intensified neoadjuvant chemoradiotherapy with irinotecan can be safely administered and results in a high pCR rate.

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“…Results expressed as percentages of patients who were evaluable at each dosage level are shown above each bar (Minsky et al, 1992a) need to monitor the results of treatment and respond appropriately. The need for more effective liaison between different clinical disciplines is illustrated by the observation that preoperative radiation therapy or combined modality therapy in patients with rectal cancer who undergo surgery may be associated with a more favourable outcome (reduced toxicity and better preservation of sphincter function) than post-operative therapy (Minsky et al, 1992ci;Rouanet et al, 1995;Hyams et al] 1997;Maghfoor et al, 1997). An example of how patient-centred end-points such as reduced incidence of acute side-effects and the avoidance of permanent colostomy might be used to improve the overall effectiveness of treatment is shown by the following data from the Memorial Sloan-Kettering Cancer Center (Minsky et al, 1992a).…”

Section: Designing Therapies To Enhance Patient-centred Outcomesmentioning

confidence: 99%

Multidisciplinary case teams: an approach to the future management of advanced colorectal cancer

Minsky

1998

Br J Cancer

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Summary The effective management of advanced colorectal cancer has traditionally been viewed in terms of treatment outcome measures such as efficacy (survival, objective response and palliation) and safety. Although these outcomes are of paramount importance and are essential for the evaluation of the effectiveness and tolerability of treatment, they do not take account of the global effect of therapy on patients, society and healthcare systems. Furthermore, they may not reveal important differences between treatments of equivalent antitumour efficacy that might influence the overall effectiveness in terms of acceptability of therapy. To achieve this, a broader, patient-centred evaluation of advanced cancer treatment is required that acknowledges the views, experience and perspectives of all involved in the treatment process. To this end, the International Working Group in Colorectal Cancer, a multidisciplinary group that encompasses expertise from a range of relevant fields and disciplines, has advocated a multidisciplinary approach to the treatment of advanced colorectal cancer that is likely to deliver the best possible overall care.

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A clinical trial to evaluate the worth of preoperative multimodality therapy in patients with operable carcinoma of the rectum

Cited by 347 publications

References 26 publications

Pathologic complete response to neoadjuvant therapy in patients with pancreatic ductal adenocarcinoma is associated with better prognosis

Pathologic complete response to neoadjuvant therapy in patients with pancreatic ductal adenocarcinoma is associated with better prognosis

Intensified concurrent chemoradiotherapy with 5-fluorouracil and irinotecan as neoadjuvant treatment in patients with locally advanced rectal cancer

Multidisciplinary case teams: an approach to the future management of advanced colorectal cancer

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