Adjuvant postoperative fluorouracil-modulated chemotherapy combined with pelvic radiation therapy for rectal cancer: initial results of intergroup 0114.

Mamon

et al. 2010

Cancer

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.

Section: Original Articlementioning

confidence: 83%

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

Mamon

et al. 2010

Cancer

“…26 One report recommended caution in the interpretation of the subgroup analyses, because the gender analysis was not planned in advance. 28 Those authors also pointed out that their results suggested that dosing schemes may need to be different for men and women and that other studies of adjuvant treatment in patients with colorectal carcinoma should evaluate gender-related differences. 28 The study that reported higher rates of pretreatment distress among women recommended that women may need more psychological support before treatment and early in the course of treatment.…”

Section: Resultsmentioning

confidence: 99%

“…28 Those authors also pointed out that their results suggested that dosing schemes may need to be different for men and women and that other studies of adjuvant treatment in patients with colorectal carcinoma should evaluate gender-related differences. 28 The study that reported higher rates of pretreatment distress among women recommended that women may need more psychological support before treatment and early in the course of treatment. 27 That study was done specifically to evaluate quality-of-life differences between women and men with lung cancer, because increasing numbers of women are affected by lung cancer.…”

Section: Resultsmentioning

confidence: 99%

“…Two treatment trials and three prevention trials stated that gender subgroup analyses were based on data from previously published reports, and two treatment trials and three prevention trials stated that specific gender hypotheses were being tested. The reports of gender subgroup analyses of treatment outcome showed a higher rate of toxicity among women, 26 higher levels of pretreatment psychological distress among women, 27 a greater proportion of recurrences and treatment failures among women, 28 lower levels of recurrence among women, 29 better response to therapy among women, 30 worse survival among men, 24 and a lower mortality rate among women. 26 One report recommended caution in the interpretation of the subgroup analyses, because the gender analysis was not planned in advance.…”

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Selection and description of cancer clinical trials participants—Science or happenstance?

Swanson

Bailar

2002

Cancer

BACKGROUNDThe selection of clinical trials participants is a critical step in study design, because it affects the generalizability of recommendations made on the basis of trial results and public acceptance of medical research. The authors assessed the heterogeneity of subgroups in cancer treatment and prevention trials and the analysis of subgroups in the evaluation of trial outcomes.METHODSThe authors reviewed published reports (1990–2000) of cancer prevention and treatment trials from 11 journals. They report here on all Phase III cancer treatment and prevention trials that had at least 100 participants and were conducted among adults in the United States. A structured abstract was developed and used to extract data from the 261 published reports. Descriptive summaries of the abstracted data provided the information included in this systematic review.RESULTSAge and gender of study participants were reported in more than 90% of these trials, whereas fewer than 30% of the trials reported race or ethnicity. Gender was reported as an explicit criterion for participant selection primarily in studies of gender specific malignancies. Race and ethnicity were reported as explicit selection criteria for participant selection for five of the prevention trials and for none of the cancer treatment trials. The 105 treatment trials that reported including both men and women had 42,355 participants, and 38.6% of those participants were women. The 26 prevention trials that reported including both men and women had 73,995 participants, and 34.7% of those participants were women. Fifty‐seven treatment trials reported participant ethnic diversity: There were 45,815 participants, with 10.5% African‐American participants and with less than 1% Hispanic, Asian, or Native American participants. Seventeen prevention trials reported participant ethnic diversity: There were 91,741 participants, with 5.5% African‐American participants, 1.7% Hispanic participants, and less than 1% Asian or Native American participants.CONCLUSIONSCancer treatment and prevention trial reports provide scant information about participant race and ethnicity. Such studies use participant selection criteria that do not define diverse subgroups, and few subgroup analyses are conducted. Improvements in the selection, reporting, and analysis of clinical trials participants are needed. Cancer 2002;95:950–9. © 2002 American Cancer Society.DOI 10.1002/cncr.10785

“…Distal rectal cancer operations are still a challenge, even for experienced surgeons, where laparoscopic approach is gaining popularity, and neo-adjuvant therapy is a standard for II-nd and III stage of the disease. 1,2 Laparoscopic, compared to conventional operations have been advocated to have less complications, 3 concerning the most common ones -surgical site infection (SSI), anastomosis leakage, post-operative ileus and bleeding, all assessed by Clavien-Dindo classification. 4 Anastomosis insufficiency rate in colorectal surgery varies from 2 to 26%, 5,6 being higher in low and ultralow rectum resections.…”

Section: Introductionmentioning

confidence: 99%

Benefit of extraperitonization to prevent septic intraabdominal complications after distal rectal cancer surgery

Atanasov

Sakakushev

2016

J Peritoneum

Colorectal cancer is one of the most common oncological diseases. Surgery is the main treatment modality and laparoscopic colorectal resection has been gaining popularity over the past two decades. Neoadjuvant therapy is considered standard treatment for 2 nd and 3 rd stage distal rectal cancer. We present our retrospective study of 127 patients with anterior rectum resection (ARR) and total mesorectal excision (TME) for low rectal cancer operated on between 2012 and 2015 in two surgical wards. In all 59 laparoscopic ARR neoadjuvant therapy, intraabdominal drainage and ileostomy was performed, while extra-peritonization was done in 21 and no pre-sacral drainage was used. In the conventional group of 68 ARR, 21 had neo-adjuvant therapy, everyone has had extra-peritonization, pre-sacral drainage and no protective ileostomy performed. Early postoperative complications were registered in 25 patients, 24 related to the operation and 1 due to a recurrent brain stroke, all classified from I to III by Clavien Dindo scale. There were 9 anastomosis insufficiences: 6 in conventional and 3 in laparoscopic operations. In 3 patients (2 conventional and 1 laparoscopic) with low ARR and signs of peritoneal contamination re-laparotomy was performed with successive outcome. All patients survived. Our routine practice of extra-peritonization and pre-sacral-perianal drainage in open ARR eliminate the possibility of postoperative peritonitis after anastomosis insufficiency, limiting the infection to low pelvic phlegmona and local intra-abdominal pelvic infection in overlooked cases.