Although neoadjuvant chemoradiotherapy achieves low local recurrence rates in clinical stages II to III rectal cancer, it delays administration of optimal chemotherapy. We evaluated preoperative ...infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX)/bevacizumab with selective rather than consistent use of chemoradiotherapy.
Thirty-two patients with clinical stages II to III rectal cancer participated in this single-center phase II trial. All were candidates for low anterior resection with total mesorectal excision (TME). Patients were to receive six cycles of FOLFOX, with bevacizumab included for cycles 1 to 4. Patients with stable/progressive disease were to have radiation before TME, whereas responders were to have immediate TME. Postoperative radiation was planned if R0 resection was not achieved. Postoperative FOLFOX × 6 was recommended, but adjuvant regimens were left to clinician discretion. The primary outcome was R0 resection rate.
Between April 2007 and December 2008, 32 (100%) of 32 study participants had R0 resections. Two did not complete preoperative chemotherapy secondary to cardiovascular toxicity. Both had preoperative chemoradiotherapy and then R0 resections. Of 30 patients completing preoperative chemotherapy, all had tumor regression and TME without preoperative chemoradiotherapy. The pathologic complete response rate to chemotherapy alone was 8 of 32 (25%; 95% CI, 11% to 43%). The 4-year local recurrence rate was 0% (95% CI, 0% to 11%); the 4-year disease-free survival was 84% (95% CI, 67% to 94%).
For selected patients with clinical stages II to III rectal cancer, neoadjuvant chemotherapy and selective radiation does not seem to compromise outcomes. Preoperative Radiation or Selective Preoperative Radiation and Evaluation Before Chemotherapy and TME (PROSPECT), a randomized phase III trial to validate this experience, is now open in the US cooperative group network.
The watch-and-wait (WW) strategy aims to spare patients with rectal cancer unnecessary resection.
To analyze the outcomes of WW among patients with rectal cancer who had a clinical complete response ...to neoadjuvant therapy.
This retrospective case series analysis conducted at a comprehensive cancer center in New York included patients who received a diagnosis of rectal adenocarcinoma between January 1, 2006, and January 31, 2015. The median follow-up was 43 months. Data analyses were conducted from June 1, 2016, to October 1, 2018.
Patients had a clinical complete response after completing neoadjuvant therapy and agreed to a WW strategy of active surveillance and possible salvage surgery (n = 113), or patients underwent total mesorectal excision and were found to have a pathologic complete response (pCR) at resection (n = 136).
Kaplan-Meier estimates were used for analyses of local regrowth and 5-year rates of overall survival, disease-free survival, and disease-specific survival.
Compared with the 136 patients in the pCR group, the 113 patients in the WW group were older (median range, 67.2 32.1-90.9 vs 57.3 25.0-87.9 years, P < .001) with cancers closer to the anal verge (median range height from anal verge, 5.5 0.0-15.0 vs 7.0 0.0-13.0 cm). All 22 local regrowths in the WW group were detected on routine surveillance and treated by salvage surgery (20 total mesorectal excisions plus 2 transanal excisions). Pelvic control after salvage surgery was maintained in 20 of 22 patients (91%). No pelvic recurrences occurred in the pCR group. Rectal preservation was achieved in 93 of 113 patients (82%) in the WW group (91 patients with no local regrowths plus 2 patients with local regrowths salvaged with transanal excision). At 5 years, overall survival was 73% (95% CI, 60%-89%) in the WW group and 94% (95% CI, 90%-99%) in the pCR group; disease-free survival was 75% (95% CI, 62%-90%) in the WW group and 92% (95% CI, 87%-98%) in the pCR group; and disease-specific survival was 90% (95% CI, 81%-99%) in the WW group and 98% (95% CI, 95%-100%) in the pCR group. A higher rate of distant metastasis was observed among patients in the WW group who had local regrowth vs those who did not have local regrowth (36% vs 1%, P < .001).
A WW strategy for select rectal cancer patients who had a clinical complete response after neoadjuvant therapy resulted in excellent rectal preservation and pelvic tumor control; however, in the WW group, worse survival was noted along with a higher incidence of distant progression in patients with local regrowth vs those without local regrowth.
The purpose of this study was to describe the frequency of interventions necessary to palliate the intact primary tumor in patients who present with synchronous, stage IV colorectal cancer (CRC) and ...who receive up-front modern combination chemotherapy without prophylactic surgery.
By using a prospective institutional database, we identified 233 consecutive patients from 2000 through 2006 with synchronous metastatic CRC and an unresected primary tumor who received oxaliplatin- or irinotecan-based, triple-drug chemotherapy (infusional fluorouracil, leucovorin, and oxaliplatin; bolus fluorouracil, leucovorin, and irinotecan; or fluorouracil, leucovorin, and irinotecan) with or without bevacizumab as their initial treatment. The incidence of subsequent use of surgery, radiotherapy, and/or endoluminal stenting to manage primary tumor complications was recorded.
Of 233 patients, 217 (93%) never required surgical palliation of their primary tumor. Sixteen patients (7%) required emergent surgery for primary tumor obstruction or perforation, 10 patients (4%) required nonoperative intervention (ie, stent or radiotherapy), and 213 (89%) never required any direct symptomatic management for their intact primary tumor. Of those 213 patients, 47 patients (20%) ultimately underwent elective colon resection at the time of metastasectomy, and eight patients (3%) underwent this resection during laparotomy for hepatic artery infusion pump placement. Use of bevacizumab, location of the primary tumor in the rectum, and metastatic disease burden were not associated with increased intervention rate.
Most patients with synchronous, stage IV CRC who receive up-front modern combination chemotherapy never require palliative surgery for their intact primary tumor. These data support the use of chemotherapy, without routine prophylactic resection, as the appropriate standard practice for patients with neither obstructed nor hemorrhaging primary colorectal tumors in the setting of metastatic disease.
Intensity-modulated radiation treatment (IMRT) is increasingly used in the treatment of squamous cell carcinoma of the anal canal (SCCAC). Prevention of locoregional failure (LRF) using IMRT requires ...appropriate clinical target volume (CTV) definition. To better define the CTV for IMRT, we evaluated patterns and predictors of LRF in SCCAC patients given conventional radiation treatment.
We reviewed records of 180 SCCAC patients treated with conventional radiation with or without chemotherapy at our institution between January 1990 and March 2007. All patients received radiation; the median primary tumor dose was 45 Gy. A total of 173 patients also received mitomycin-based chemotherapy.
Median follow-up was 40 months. Actuarial 3-year colostomy-free survival was 89% and overall survival (OS) 88%. Actuarial 3-year LRF was 23%. A total of 45 patients had LRF, with 35 (78%) occurring locally in the primary site (25 local only, 10 local and regional); however, 20 (44%) had regional components of failure within the pelvis or inguinal nodes (10 regional only, 10 local and regional). Cumulative sites of LRF (patients may have one or more site of failure) were as follows: primary, 35; inguinal, 8; external perianal, 5; common iliac, 4; presacral, 3; distal rectum, 2; external iliac, 2; and internal iliac, 2. All patients with common iliac failure had cT3 or N+ disease.
The observed patterns of failure support inclusion of the inguinal and all pelvic nodal groups in the CTV for IMRT. In patients with advanced tumor or nodal stage, common iliac nodes should also be included in the CTV.
Purpose
Cancer impacts caregivers as well as patients. Ambulatory oncology surgeries requiring a short hospital stay place additional responsibility on informal caregivers as they help patients ...navigate their post-operative recovery at home, and determine if symptoms are expected or emergent. Our objective was to explore the experience of informal caregivers during patients’ ambulatory cancer surgery and then recovery at home with remote monitoring of symptoms via web-based patient-reported outcomes questionnaire (“Recovery Tracker”).
Methods
Semi-structured interviews were conducted with caregivers from a larger sample participating in a randomized trial of the Recovery Tracker. Thematic analysis was applied to derive key themes and codes via NVivo qualitative analysis software (QSR International Inc.). Recruitment was conducted iteratively to ensure a heterogenous sample and thematic saturation.
Results
Twenty-three semi-structured interviews were conducted. Four main themes emerged: (1)
Predictability reduced stress among caregivers
; (2)
Unexpected events caused stress for caregivers
; (3)
The importance of a caregiver being present during the recovery process
; and (4)
Caregiver involvement in remote monitoring of symptoms was minimal
.
Conclusion
Caregivers report not being overly burdened by the ambulatory surgery process, but they are very sensitive to any deviations from what they expected to happen. Further research and clinical practice on caregivers in the ambulatory setting should focus on how to set expectations and avoid unexpected events.
Sexual function is one element of QOL that may be significantly altered following treatment for rectal cancer, but the incidence and contributing risk factors are generally poorly understood. ...Nevertheless, the impact of rectal cancer therapy on sexual function should be conveyed to patients preoperatively. In addition to helping patients evolve realistic expectations, it will help clinicians identify those for whom interventions may be appropriate. In the past 10 years, there has been an increase in the number of studies reporting sexual dysfunction following rectal cancer treatment. However, these studies are difficult to interpret collectively for a variety of reasons. Most importantly, sexual dysfunction lacks a standardized definition, which leads to poor comparability between studies. The best inclusive definitions describe sexual dysfunction as a collection of distinct symptoms, which differ for men and women. The absence of sexual activity is sometimes used as a surrogate for sexual dysfunction, but this is confounded by an individual's desire and opportunity for sexual activity, and may not be an accurate reflection of physiologic functionality. Additional factors complicating assimilation of studies include the absence of baseline data, missing data, small sample sizes, and heterogeneity in use of validated and nonvalidated instruments. The purpose of this article is to systematically review the contemporary literature reporting sexual function after rectal surgery to determine the overall risk of sexual dysfunction, evaluate possible contributing factors, and identify questions that should be addressed in future studies.
Total neoadjuvant therapy (TNT) improves tumor response in locally advanced rectal cancer (LARC) patients compared to neoadjuvant chemoradiotherapy alone. The effect of TNT on patient survival has ...not been fully investigated.
This was a retrospective case series of patients with LARC at a comprehensive cancer center. Three hundred and eleven patients received chemoradiotherapy (chemoRT) as the sole neoadjuvant treatment and planned adjuvant chemotherapy, and 313 received TNT (induction fluorouracil and oxaliplatin-based chemotherapy followed by chemoradiotherapy in the neoadjuvant setting). These patients then underwent total mesorectal excision or were entered in a watch-and-wait protocol. The proportion of patients with complete response (CR) after neoadjuvant therapy (defined as pathological CR or clinical CR sustained for 2 years) was compared by the χ2 test. Disease-free survival (DFS), local recurrence-free survival, distant metastasis-free survival, and overall survival were assessed by Kaplan-Meier analysis and log-rank test. Cox regression models were used to further evaluate DFS.
The rate of CR was 20% for chemoRT and 27% for TNT (P=.05). DFS, local recurrence-free survival, metastasis-free survival, and overall survival were no different. Disease-free survival was not associated with the type of neoadjuvant treatment (hazard ratio HR 1.3; 95% confidence interval CI 0.93-1.80; P = .12).
Although TNT does not prolong survival than neoadjuvant chemoradiotherapy plus intended postoperative chemotherapy, the higher response rate associated with TNT may create opportunities to preserve the rectum in more patients with LARC.
Purpose Physical activity (PA) is positively associated with numerous health benefits among cancer survivors. This study examined insufficiently investigated relationships among PA, health-related ...quality of life (HRQOL), and bowel function (BF) in rectal cancer survivors. Methods RC survivors (n = 1063) ≥5 years from diagnosis in two Kaiser permanente regions were mailed a multidimensional survey to assess HRQOL and BF. PA was assessed by a modified Godin Leisure-Time Exercise Questionnaire. PA minutes were categorized into weighted categories based on guidelines: (1) not active (zero PA minutes); (2) insufficiently active (1-149 PA minutes); (3) meeting guidelines (150-299 PA minutes); and (4) above guidelines (≥300 PA minutes). Relationships of PA with HRQOL and BF were evaluated using multiple linear regression, stratified by sex and ostomy status for BF. Types of PA identified as helpful for BF and symptoms addressed were summarized. Results Response rate was 60.5%. Of 557 participants, 40% met or exceeded PA guidelines, 34% were not active, and 26% were insufficiently active. Aerobic activities, specifically walking and cycling, were most commonly reported to help BF. Higher PA was associated with better psychological wellbeing and multiple SF12 scales, worse BF scores in men with ostomies, and better BF scores in women. Conclusions Meeting or exceeding PA guidelines was associated with higher HRQOL. Although the BF findings are exploratory, they suggest women may benefit from increased PA, whereas men with ostomies may face challenges that require more study. Identifying PA strategies that will lead to improved patient compliance and benefit are needed.