Adjuvant versus Neoadjuvant Radiochemotherapy for Locally Advanced Rectal Cancer A Progress Report of a Phase-III Randomized Trial (Protocol CAO/ARO/AIO-94)

Sauer, Rolf; Fietkau, Rainer; Wittekind, Christian; Martus, Peter; Rödel, Claus; Hohenberger, Werner; Jatzko, G.; Sabitzer, H; Karstens, Johann-Hinrich; Becker, Heinz; Hess, Clemens F.; Raab, R.

doi:10.1007/pl00002396

Cited by 121 publications

(62 citation statements)

References 25 publications

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“…Clinical trials commonly report physiciangraded diarrhea, which may not fully capture the QOL effects from the patient's perspective and may underrepresent the true prevalence of this symptom. Although previous studies have reported an approximately 30% rate of physician-reported, acute, grade 2 to 5 diarrhea, [1][2][3]5 in clinical practice, it is observed more commonly. In addition, other treatment-related, acute GI symptoms are observed frequently in the clinic but are not described well in the literature.…”

Section: Original Articlementioning

confidence: 78%

Patient‐reported acute gastrointestinal symptoms during concurrent chemoradiation treatment for rectal cancer

Chen

Mamon

Chen

et al. 2010

Cancer

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BACKGROUND:Although it is known that standard 5-fluorouracil-based chemoradiation therapy for rectal cancer causes significant acute gastrointestinal (GI) toxicity, research on patient-reported outcomes (PROs) is limited. The authors undertook the current study to assess the feasibility of incorporating PRO measurement into routine clinical practice and to describe the trajectory of symptom development during treatment. METHODS: Seventy-seven consecutive patients who were treated between 2006 and 2008 were eligible. Patients completed the 7-item Bowel Problems Scale immediately before weekly physician visits. RESULTS: The questionnaire completion rate was 95%. Individual GI symptoms had different trajectories of development. By Week 5, approximately 40% of all patients developed clinically meaningful pain, bowel urgency, or tenesmus that was not present during Week 1; 30% developed diarrhea, abdominal cramping, and passing mucus. However, overall symptom burden was moderate. Seventyfive percent of patients who presented with rectal bleeding at Week 1 improved by Week 3 of treatment. Within each physician-assessed grade of diarrhea, patient experience varied widely. For example, of the 50 patients who developed grade 2 diarrhea on the Radiation Therapy Oncology Group Acute Morbidity Scale, the numbers of patients reporting only occasional symptoms versus those reporting frequent or very frequent symptoms were similar. CONCLUSIONS: PROs provided information on patient symptoms during chemoradiation treatment for rectal cancer that was not captured otherwise, and it was feasible to incorporate PROs into routine clinical practice. The current results may be used by physicians to counsel their patients before treatment initiation and to provide a benchmark against which trials that use new therapies may be compared.

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Section: Original Articlementioning

confidence: 78%

Patient‐reported acute gastrointestinal symptoms during concurrent chemoradiation treatment for rectal cancer

Chen

Mamon

Chen

et al. 2010

Cancer

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“…However, increased toxicity and a slight increase in early deaths were seen in the preoperative arm. The German CAO/ARO/AIO-94 study showed that preoperative chemoradiation was well tolerated and carried no higher risk of postoperative morbidity, but efficacy data are awaited (Sauer et al, 2001).…”

Section: Discussionmentioning

confidence: 99%

“…The potential disadvantage of preoperative CRT is overtreatment of patients either because of early pathological stage (estimated to be 18% in one randomised study (Sauer et al, 2001)) or presence of occult metastatic disease undetected on pretreatment imaging. Preoperative CRT has been used by many oncologists especially in North America for patients with clinical T3 disease based on extrapolated benefits from postoperative CRT and a number of nonrandomised studies demonstrating significant pathological complete response (pCR) rates and acceptable acute toxicity profile with the use of preoperative CRT.…”

mentioning

confidence: 99%

Neoadjuvant systemic fluorouracil and mitomycin C prior to synchronous chemoradiation is an effective strategy in locally advanced rectal cancer

et al. 2003

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This study was designed to evaluate the benefits of neoadjuvant chemotherapy prior to chemoradiation and surgery in patients with locally advanced rectal cancer. Patients with previously untreated primary rectal cancer, reviewed in a multidisciplinary meeting and considered to have locally advanced disease on the basis of physical examination and imaging (MRI+CT n ¼ 30, CT alone n ¼ 6), were recruited. Patients received protracted venous infusion 5-FU (300 mg m À2 day À1 for 12 weeks) with mitomycin C (MMC) (7 mg m À2 i.v. bolus every 6 weeks). Starting on week 13, 5-FU was reduced to 200 mg m À2 day À1 and concomitant pelvic radiotherapy 45 Gy in 25 fractions was commenced followed by 5.4 -9 Gy boost to tumour bed. Surgery was planned 6 weeks after chemoradiation. Postoperatively, patients received 12 weeks of MMC and 5-FU at the same preoperative doses. Between January 99 and August 01, 36 eligible patients were recruited. Median age was 63 years (range ¼ 40 -85). Following neoadjuvant chemotherapy, radiological tumour response was 27.8% (one CR and nine PRs) and no patient had progressive disease. In addition, 65% of patients had a symptomatic response including improvement in diarrhoea/constipation (59%), reduced rectal bleeding (60%) and diminished pelvic pain/tenesmus (78%). Following chemoradiation, tumour regression occurred in 80.6% (six CRs and 23 PRs; 95% CI ¼ 64 -91.8%) and only one patient still had an inoperable tumour. R0 resection was achieved in 28 patients (82%). When compared with initial clinical staging, the pathological downstaging rate in T and/or N stage was 73.5% and pathological CR was found in one patient. Neoadjuvant systemic chemotherapy as a prelude to synchronous chemoradiation can be administered with negligible risk of disease progression and produces considerable symptomatic response with associated tumour regression.

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“…The preoperative therapy tended to be more toxic than the postoperative (grade 4/5 toxicity 34% vs. 24%, p0/0.07). A large German trial, presently still recruiting patients, has a similar design (45). The neoadjuvant therapy is well tolerated in the trial and bears no higher risk for postoperative morbidity.…”

Section: Sphincter Preservation After Preoperative Radiationmentioning

confidence: 99%

A Systematic Overview of Radiation Therapy Effects in Rectal Cancer

et al. 2003

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Adjuvant versus Neoadjuvant Radiochemotherapy for Locally Advanced Rectal Cancer A Progress Report of a Phase-III Randomized Trial (Protocol CAO/ARO/AIO-94)

Abstract: The patient accrual of our trial is satisfactory, neoadjuvant radiochemotherapy is well tolerated and bears no higher risk for postoperative morbidity.

Cited by 121 publications

References 25 publications

Patient‐reported acute gastrointestinal symptoms during concurrent chemoradiation treatment for rectal cancer

Patient‐reported acute gastrointestinal symptoms during concurrent chemoradiation treatment for rectal cancer

Neoadjuvant systemic fluorouracil and mitomycin C prior to synchronous chemoradiation is an effective strategy in locally advanced rectal cancer

A Systematic Overview of Radiation Therapy Effects in Rectal Cancer

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