Relationship of acute gastrointestinal toxicity and the volume of irradiated small bowel in patients receiving combined modality therapy for rectal cancer.

1995 ◽  
Vol 13 (6) ◽  
pp. 1409-1416 ◽  
Author(s):  
B D Minsky ◽  
J A Conti ◽  
Y Huang ◽  
K Knopf
Keyword(s):  
Rectal Cancer ◽  
Small Bowel ◽  
Radiation Field ◽  
Combined Modality Therapy ◽  
High Dose ◽  
Pelvic Radiation ◽  
Postoperative Therapy ◽  
Combined Modality ◽  
Gi Toxicity ◽  
Experienced Grade

PURPOSE To determine the relationship between acute gastrointestinal (GI) toxicity during the combined modality segment and the volume of small bowel in the pelvic radiation field in patients who receive either preoperative or postoperative therapy for rectal cancer. PATIENTS AND METHODS The patient population was derived from four consecutive phase I dose-escalation trials. Combined modality therapy included fluorouracil (5-FU), leucovorin ([LV] bolus daily x 5, days 1 and 29), and pelvic radiation. RESULTS Twenty patients who received postoperative therapy had a larger volume of small bowel in the pelvic radiation field as compared with 60 who received preoperative therapy (462 +/- 129 v 212 +/- 44 cm3, P = .002). The most significant relationship between acute GI toxicity and volume of small bowel was seen in 12 patients who were treated on the preoperative sequential low-dose LV trial, all of whom received the maximum-tolerated dose (MTD) of 5-FU. The volume of small bowel in patients who experienced grade 3+ toxicity was 731 +/- 274 cm3, as compared with 145 +/- 58 in those who experienced grade 0 to 2 toxicity (P = .005). Likewise, logistic regression analysis showed that 26 patients who received the MTD of 5-FU had the most significant association between GI toxicity and volume of small bowel (P = .036). CONCLUSION Our data suggest that the volume of small bowel in the pelvic radiation field may be dose-limiting in the delivery of high-dose 5-FU when combined with LV and radiation therapy.

Combined modality therapy of rectal cancer: decreased acute toxicity with the preoperative approach.

1992 ◽  
Vol 10 (8) ◽  
pp. 1218-1224 ◽  
Author(s):  
B D Minsky ◽  
A M Cohen ◽  
N Kemeny ◽  
W E Enker ◽  
D P Kelsen ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Acute Toxicity ◽  
Randomized Trials ◽  
Combined Modality Therapy ◽  
High Dose ◽  
Phase I Trials ◽  
Postoperative Therapy ◽  
Combined Modality ◽  
High Incidence ◽  
Grade 3

PURPOSE We compared the combined radiation therapy (RT) plus chemotherapy segments of two separate parallel phase I trials to determine if combined pelvic RT, fluorouracil (5-FU), and high-dose leucovorin (LV) had less acute toxicity when delivered preoperatively versus postoperatively in patients with rectal cancer. PATIENTS AND METHODS Patients with unresectable disease received preoperative RT plus LV and 5-FU followed by surgery and postoperative LV and 5-FU. Patients with resectable disease received identical doses, techniques, and schedules of RT and LV and 5-FU except all therapy was delivered postoperatively. On day 1, patients received LV and 5-FU times one cycle. RT began on day 8. A second cycle of LV and 5-FU was given concurrently with the fourth week of RT. RESULTS Although more patients (75% v 32%; P = .02) received the higher dose level of 5-FU (250 mg/m2), significantly fewer experienced acute grade 3 to 4 toxicity with preoperative versus postoperative therapy (13% v 48%; P = .045). There was no grade 3 to 4 myelosuppression in either group. The two grade 3 toxicities in the preoperative group were gastrointestinal. The grade 3 toxicities in the postoperative group included seven gastrointestinal and two genitourinary; four patients had a grade 4 toxicity. CONCLUSION Given the high incidence of grade 3 to 4 toxicity also reported in the postoperative combined modality adjuvant randomized trials, future adjuvant trials should explore the preoperative approach.

Radiation therapy for rectosigmoid and rectal cancer: results of the 1992-1994 Patterns of Care process survey.

1998 ◽  
Vol 16 (7) ◽  
pp. 2542-2547 ◽  
Author(s):  
B D Minsky ◽  
L Coia ◽  
D G Haller ◽  
J Hoffman ◽  
M John ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Rectal Cancer ◽  
Radiation Therapy ◽  
Radiation Treatment ◽  
Combined Modality Therapy ◽  
Care Process ◽  
Cluster Sampling ◽  
Intraoperative Radiation ◽  
Postoperative Therapy ◽  
Combined Modality

PURPOSE To determine the US national practice standards for patients with adenocarcinoma of the rectum treated in radiation oncology facilities. MATERIALS AND METHODS A national survey of 57 institutions identified 507 eligible patients who received radiation therapy as a component of their treatment for rectal cancer. A stratified two-stage cluster sampling with simple random sampling at each stage for each stratum was used and on-site surveys were performed. RESULTS Of the 507 patients, 378 (75%) received postoperative therapy, 110 (22%) received preoperative therapy, 17 (2%) received both preoperative and postoperative therapy, and less than 0.5% received intraoperative radiation alone. To more accurately assess the utilization of modern radiation techniques as well as recommendations of the National Cancer Institute (NCI)-sponsored, randomized, postoperative, adjuvant combined modality therapy rectal cancer trials into current practice, the analysis was limited to the 243 (48%) patients with tumor, node, and metastasis staging system classification T3 and/or N1-2M0 disease who underwent conventional surgery with negative margins. Although only 7% were treated on a clinical trial, 90% received chemotherapy for a median of 21 weeks. Most were treated with modern radiation treatment techniques. In contrast, techniques to identify and help exclude the small bowel from the radiation field were not routinely used. CONCLUSION Despite the fact that only 7% of patients with T3 and/or N1-2M0 disease were treated on a clinical trial, such trials appear to have resulted in a positive influence on the standard of practice within the oncology community. Although there are still some deficiencies, the majority of these patients received combined modality therapy and were treated with modern radiation therapy techniques.

scholarly journals Disparity in the use of combined modality therapy for rectal cancer in the older adult

2013 ◽  
Vol 4 (1) ◽  
pp. 90-97 ◽  
Author(s):  
Gerald C. Bohac ◽  
Delia Guaqueta ◽  
Debbie M. Cheng ◽  
Ann Aschengrau ◽  
Kevan L. Hartshorn
Keyword(s):  
Rectal Cancer ◽  
Older Adult ◽  
Combined Modality Therapy ◽  
Combined Modality

Predictive clinicopathologic factors for limited response of T3 rectal cancer to combined modality therapy

2007 ◽  
Vol 23 (3) ◽  
pp. 243-249 ◽  
Author(s):  
Anne Y. Lin ◽  
W. Douglas Wong ◽  
Jinru Shia ◽  
Bruce D. Minsky ◽  
Larissa K. Temple ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Combined Modality Therapy ◽  
Combined Modality ◽  
Clinicopathologic Factors ◽  
T3 Rectal Cancer

Phase II study of low dose (LD) and high dose (HD) premarin in androgen independent prostate cancer (AIPC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4560-4560 ◽  
Author(s):  
M. Pomerantz ◽  
J. Manola ◽  
M. Taplin ◽  
G. Bubley ◽  
M. Inman ◽  
...  
Keyword(s):  
Warfarin Dose ◽  
High Dose ◽  
Clinical Predictors ◽  
Predictors Of Response ◽  
Psa Response ◽  
Transdermal Estradiol ◽  
Gi Toxicity ◽  
Grade 3 ◽  
Experienced Grade

4560 Background: Estrogens, including DES, transdermal estradiol, estramustine and PC-SPES, have shown antitumor activity in AIPC. We tested two doses of Premarin to determine efficacy and safety of this commonly available estrogen. Methods: Patients with progressive AIPC were eligible. Prior estrogen use, significant cardiac or thromboembolic disease, and concurrent steroids were not allowed. Patients were randomized to Premarin 1.25 mg once (LD) or 3 times (HD) daily. Prophylactic breast irradiation was encouraged and warfarin 1 mg daily was required, unless contraindicated. After the first stage of accrual, the LD arm was closed because of limited activity, while the HD arm continued to the 2nd stage. Results: 46 patients were enrolled; 17 patients were randomized to LD Premarin, 29 patients assigned to HD Premarin by randomization or direct assignment. One patient withdrew consent prior to therapy. Median follow up is 5.3 months. Median age was 69 years (range 52–86) and median PSA 84.6 ng/ml (range 2.5–794.1). 19 patients (41%) had measurable disease. PSA declines ≥ 50% were seen in 0% (95% C.I., 0–19.5) and 32.1% (95% C.I., 15.9–52.4) of patients treated with LD and HD premarin. 1 patient treated with HD Premarin had a partial measurable response (8.3%; 95% C.I., 0.2–38.5). Median time to progression was 3.3 and 3.2 months in the LD and HD arms, respectively. Premarin was well tolerated in 45 evaluable patients. One grade 4 toxicity was noted, a stroke in the LD arm. Grade 3 toxicity was rare with 1 allergic reaction, 2 DVTs and 3 episodes of GI toxicity in one patient. Two patients experienced grade 3 elevations in PT requiring modification of warfarin dose. No significant gynecomastia was reported. Analysis of serially drawn hormone levels and molecular correlates of treatment response is pending. Conclusions: HD Premarin is associated with a 32.1% PSA response rate, while no responses were seen with LD Premarin. A measurable response was noted in 1 of 12 patients treated with HD Premarin. Toxicity was modest, though thromboembolism was seen even with prophylactic warfarin. Ongoing studies are evaluating molecular and clinical predictors of response. No significant financial relationships to disclose.

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