Comparison of chemoradiotherapy (CRT) using carboplatin/paclitaxel (CP) versus cisplatin/5-FU (CF) for esophageal or gastroesophageal junctional (GEJ) cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 4053-4053 ◽  
Author(s):  
Hao-Wen Sim ◽  
Bryan Anthony Chan ◽  
Akina Natori ◽  
Charles Henry Lim ◽  
Di Maria Jiang ◽  
...  

4053 Background: For resectable esophageal or GEJ cancer, trimodality therapy improves survival compared to surgery alone and represents the current standard of care. The optimal CRT regimen for neoadjuvant or definitive treatment of locoregional esophageal or GEJ cancer remains uncertain. Methods: A retrospective comparison of CF and CP for locoregional esophageal or GEJ cancer (2011-2015) was performed. Overall survival (OS) and disease-free survival (DFS) were assessed using multivariable Cox proportional hazards regression, controlling for age, performance status and Charlson comorbidity index. Results: 101 patients (pts) were identified (61 CF, 40 CP). 75% were male. Median age was 62 years (range 30-84). Primary sites were esophageal (52%, with 65% squamous histology) and GEJ (48%). Surgery was undertaken in 34 (56%) CF and 27 (68%) CP pts. Median follow-up was 43 months. Overall, there was a non-significant trend for improved OS with CF compared to CP (HR 0.61, 95% CI 0.33-1.14, p = 0.12). In the subgroup having surgery (N = 61), we found no significant difference in OS (HR 0.99, 95% CI 0.39-2.55, p = 0.99). In the subgroup without surgery (N = 40), CF was significantly superior to CP (HR 0.21, 95% CI 0.08-0.53, p < 0.001). Comparing only pts in this subgroup who received equitable radiation doses (N = 33), CF was still significantly superior to CP (HR 0.09, 95% CI 0.03-0.32, p < 0.001). OS was similar by histology (adenocarcinoma/squamous) in all-comers (p = 0.54), and in CF (p = 0.90) and CP subgroups (p = 0.63). DFS results corresponded with OS. There was a non-significant numerical difference in pCR rates between CF (31%) and CP (18%) (p = 0.35), which were lower than previously reported. Conclusions: Survival is similar for CF and CP CRT regimens in pts undergoing trimodality therapy, but for those who do not proceed to surgery, it appears that CF is more effective than CP. Clinicians may prefer CP for surgical candidates given its favourable toxicity profile. However, when treating with definitive CRT, CF may be preferable to CP as a standard regimen.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 126-126
Author(s):  
Hao-Wen Sim ◽  
Bryan Chan ◽  
Akina Natori ◽  
Charles Henry Lim ◽  
Di Maria Jiang ◽  
...  

126 Background: The optimal CRT regimen for neoadjuvant or definitive treatment of locoregional esophageal or gastroesophageal junctional (GEJ) cancer is uncertain. There has been no direct comparison between concurrent Cisplatin/5-FU (CF) as per the CALGB 9781 trial (50.4 Gy) or Carboplatin/Paclitaxel (CP) as per the CROSS trial (41.4 Gy). Methods: A retrospective analysis comparing CF and CP was performed in all patients (pts) with locoregional esophageal or GEJ cancer treated in 2012-2014. Overall survival (OS) and disease-free survival (DFS) were assessed via uni- and multivariable Cox proportional hazards regression, adjusting for age, performance status and Charlson comorbidity index. Pathological complete response (pCR) rates were compared using Fisher’s exact test. Results: 64/86 (74%) pts were male. Median age was 64 years (range: 34-84). Primary sites were esophageal (56%, with 60% squamous histology) and GEJ (44%, with 11% squamous). 22 pts received CRT in 2012 (100% CF), 33 pts in 2013 (58% CF, 42% CP) and 31 pts in 2014 (16% CF, 84% CP). Surgery was undertaken in 19 (41%) CF and 27 (68%) CP pts. Median follow-up was 38 months. We found no significant OS difference between CF and CP overall (HR 0.82, 95% CI: 0.43-1.56, p = 0.55) or in the subgroup having surgery (n = 46; HR 2.01, 95% CI: 0.62-6.55, p = 0.25). However, in the subgroup without surgery (n = 40), CF (n = 27) was superior to CP (n = 13)(HR 0.11, 95% CI: 0.03-0.38, p < 0.001). OS was similar by histology (adenocarcinoma/squamous) in all-comers (p = 0.96), and in CF (p = 0.66) and CP subgroups (p = 0.66). DFS results were similar to OS. There was a non-significant numerical difference in pCR rates between CF (31%) and CP (18%) (p = 0.45). Conclusions: Survival is similar for CF and CP CRT regimens in patients undergoing trimodality therapy. pCR rates were comparable but lower than previously reported. In contrast, in the absence of surgical resection, CP given for CRT results in significantly inferior outcomes. Clinicians may prefer CP for surgical candidates given its toxicity profile. However, when treating with definitive CRT, CF may be preferable to CP as a standard regimen.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 3133-3133
Author(s):  
Rozana Abdul Rahman ◽  
Neethu Billy Graham Mariam ◽  
Hitesh Mistry ◽  
Sreeja Aruketty ◽  
Matt Church ◽  
...  

3133 Background: The primary objective of EPCCT (phase I and non-randomised phase II trials) is to determine the safety and tolerability of new therapeutic agents. Response rates (RR) in these trials have typically been reported at around 10-15%. Increasingly RR and survival outcomes are now investigated in EPCCT as primary or secondary objectives. Methods: Retrospective data analysis was performed on patients (pts) enrolled onto an EPCCT between January 2018 and December 2019 at The Christie NHS Foundation Trust, UK. Data on demographics, prior systemic treatment, sites of disease, performance status, comorbidities, types of therapy, RR, progression free survival (PFS), and overall survival (OS) were collected. Statistical analyses were performed with univariable and multivariable models. Objective response rate (ORR) was defined as the proportion of pts with complete response (CR) and partial response (PR). Duration of response (DOR) was from initial response to progressive disease (PD). Disease control rate (DCR) was defined as CR+PR+ stable disease (SD). Results: A total of 247 pts were treated across 46 EPCCTs. Median age 61 years; 57% female. Sixty-six percent of pts had ≥2 lines of treatment and the majority were ECOG PS 0/1 (98%). Eighty-one percent of pts had ≥2 sites of metastatic disease, and 13 major tumour types were included. Monotherapy trials (159 pts) were predominantly targeted therapies (TT; 60%), or immunotherapies (IO; 20%). Combination therapy trials (88 pts) were TT-based (68%) or IO-based (32%). Data for RR analyses was available for 231 pts. ORR across all trials was 15% (CR 2%) and DCR was 63%. The median DOR was 8.3 months (mos) (95% CI: 7.0 – 9.7) with 28% of pts responding for >6 mos and 7% for >12 mos. ORR in pooled IO treated pts was 27%, DCR was 65% with sustained response >6 mos seen in 37% of these pts. ORR in pooled TT treated pts was 9.4%, DCR was 60% and sustained response > 6 mos seen in 25% of pts. ORR for IO v TT treated pts was significantly different, p=0.007 (pearson chi square), but no significant difference was seen for DCR. Median PFS for all patients was 5.0 mos (95% CI: 4.1 – 6.0) and OS was 10.4 mos (95% CI: 8.4 – 13.0). OS for those with a PR is not reached (HR for PR v PD, 0.006 (95% CI: 0.002 – 0.18). Pts with SD appear to have significantly better OS compared to those with PD (14.6 v 4.2 mos, HR 0.2 (95% CI: 0.1 – 0.3). Multivariable Cox proportional hazards analysis for OS was significant for male gender (HR 1.9, p=0.002), presence of liver metastasis (HR 2.0, p=0.001), low Hb (HR 0.8, p=0.03) and log (LDH) (HR 1.9, p<0.001). Conclusions: Two-thirds of pts enrolled on EPCCTs benefitted in terms of DCR with significant OS improvement in those with PR and SD. Higher ORR were seen in pts receiving IO-based treatments however DCR was similar in IO and TT pts. Gender, presence of liver metastases, Hb count and LDH level contributed significantly to survival differences.


2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 189-189
Author(s):  
Akina Natori ◽  
Bryan Chan ◽  
Hao-Wen Sim ◽  
Eric Xueyu Chen ◽  
Geoffrey Liu ◽  
...  

189 Background: The optimal treatment and outcome for elderly patients (pts) with localized gastroesophageal (GE) cancer remains unclear as they are underrepresented in clinical trials. We aimed to assess survival in pts ≥ 75 years according to treatment received. Methods: A retrospective analysis was performed for all pts aged ≥ 75 years with GE cancer treated in 2012 and 2013. Frailty was measured using the Charlson comorbidity index (CCI) and ECOG performance status (PS). Overall survival (OS) and disease-free survival (DFS) were assessed via uni- and multivariable Cox proportional hazards regression, adjusting for demographics. Logistic regression analyses were used to examine factors impacting treatment choices. Results: Of 70 pts, median age was 82 years (range: 75-98), primary sites were esophageal (40%, with 61% squamous histology), GE junction (24%) and gastric (36%). Baseline characteristics included: PS: 0 (40%), 1 (39%), 2 (14%), 3 (7%); and CCI: 0 (36%), 1 (20%), 2 (21%), ≥ 3 (23%). Treatment received included surgery (33%), radiotherapy (RT) (31%); surgery plus adjuvant chemotherapy (chemo) and/or RT (9%); chemoradiation alone (7%) and 20% had no active treatment. In univariable analysis; age < 85 (p = 0.007) and surgery (p = 0.022) were associated with improved OS. Chemo and RT, either alone or in combination, did not significantly improve OS. In multivariable analysis; age < 85 (HR 0.46, 95% CI: 0.23-0.94, p = 0.034), surgery (HR 0.32, 95% CI: 0.14-0.74, p = 0.008) and CCI < 2 (HR 0.52, 95% CI: 0.27-0.99, p = 0.048) were identified as independent predictors for improved OS. Age ≥ 85 was significantly associated with omission of surgery (OR 3.61, 95% CI: 1.13-14.01, p = 0.041) but in contrast, PS ≥ 2 (p = 0.475) and CCI ≥ 2 (p = 0.939) were not predictive. Conclusions: At our institution, very few pts ≥ 75 years received multimodality therapy for localized GE cancers. Surgery was the only treatment modality associated with a significant survival advantage, and additional chemo and/or RT did not further improve OS. The only predictor for having surgery was age. Consequently, future studies should consider comprehensive assessment for surgery so that eligible elderly pts can benefit.


2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 122-122
Author(s):  
Akina Natori ◽  
Hao-Wen Sim ◽  
Bryan Anthony Chan ◽  
Peiran Sun ◽  
Stephanie Moignard ◽  
...  

122 Background: There are no phase 3 trials comparing definitive chemoradiation (bimodality) versus. perioperative chemoradiation (trimodality) for locoregional esophageal/GEJ cancer. Methods: A retrospective analysis (2011-2015) compared bimodality and trimodality therapy in patients (pts) with locoregional esophageal/GEJ cancer treated with curative intent. Overall survival (OS) and disease-free survival (DFS) were calculated from the date of diagnosis. Uni- and multivariable Cox proportional hazards regression adjusted for patient and disease factors. Results: Of 108 patients, 82 (76%) were male. Mean ages were 69.5 ± 11.0 years (bimodality; N = 41) and 60.5 ± 11.1 years (trimodality; N = 67). For bimodality pts, 37% had adenocarcinoma and 63% had squamous cell carcinoma (SCC). For trimodality pts, 79% had adenocarcinoma and 21% had SCC (p < 0.0001). Bimodality pts received a higher radiation dose compared to trimodality pts (50.1 ± 6.7 vs. 45.2 ± 6.4 Gy). Median follow-up was 49.3 months. We found no significant OS difference between bimodality (27.0 months) and trimodality therapy (29.8 months) in the overall cohort (p = 0.57) (4 year OS rate: 42% vs. 38%). In the subgroup with adenocarcinoma histology, trimodality therapy significantly improved OS and DFS compared to bimodality (OS: 31.8 vs. 10.4 months, hazard ratio (HR) 0.34, 95% confidence interval (CI) 0.18-0.66, p = 0.001; DFS: 15.0 vs. 6.7 months; HR 0.39, 95%CI 0.21-0.73, p = 0.003). In the SCC subgroup, median OS and DFS were similar (OS: not reached vs. 29.2 months, p = 0.48; DFS: 27.0 vs. 24.0, p = 0.96). Using multivariable regression with AIC backward selection, the only retained prognostic factors were treatment modality (p = 0.06) and histology (p = 0.01). Conclusions: Our findings support preferential use of trimodality therapy for pts with adenocarcinoma histology given superior OS and DFS, whereas bimodality and trimodality therapy appeared comparable in pts with SCC histology. Pending confirmation in a larger series with longer follow-up, these findings suggest differential treatment algorithms for locoregional esophageal and GEJ cancer based on tumor histology.


2021 ◽  
Author(s):  
Sunny Guin ◽  
Bobby K. Liaw ◽  
Tomi Jun ◽  
Kristin Ayers ◽  
Bonny Patel ◽  
...  

Abstract Background: Upfront docetaxel or novel hormonal agents (NHA) such as abiraterone and enzalutamide have become the standard of care for metastatic hormone sensitive prostate cancer (mHSPC). However, data comparing the efficacy of docetaxel and NHAs in this setting are limited.Patients and Methods: This was a retrospective cohort study of patients with de novo mHSPC treated with upfront docetaxel or an NHA between January 1, 2014 and April 30, 2019 within the Mount Sinai Health System. Clinical data were extracted from the medical record. The primary outcome was failure-free survival (FFS), defined as the time to next treatment. The primary predictor was treatment with docetaxel or NHA. FFS was compared between the two groups using the Kaplan Meier method and multivariable Cox proportional hazards models. We additionally assessed the prognostic value of post-treatment PSA.Results: We identified 94 de novo mHSPC patients; 52 and 42 treated with upfront docetaxel and NHAs, respectively. NHAs were associated with significantly longer FFS compared to docetaxel (20.7 vs. 10.1 months, p=0.023). In a multivariable model adjusting for demographics and clinical factors, docetaxel was independently associated with worse FFS compared to NHAs (HR 1.96, 95% CI 1.12−3.45, p=0.019). High metastasis burden patients had a significantly longer FFS with NHAs than docetaxel (25.12 vs. 9.63 months, p=0.014), while there was no significant difference in FFS among low metastasis burden patients (NHA 20.71 vs. Docetaxel 26.5 months, p=0.9). Regardless of treatment, lower post-treatment PSA levels were associated with improved FFS (58.95 vs. 11.57 vs. 9.4 months for PSA ≤0.2, 0.2-0.4, >0.4ng/ml, respectively; p<0.001) Conclusion: Comparative analysis of real-world data demonstrated longer FFS in de novo mHSPC treated with NHA compared to docetaxel. In addition, the depth of PSA response following combination treatment may hold prognostic value for mHSPC outcomes.


2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 586-586
Author(s):  
Bindu V. Manyam ◽  
Shlomo A. Koyfman ◽  
Davendra Sohal ◽  
Ismail Mallick ◽  
Chandana A. Reddy ◽  
...  

586 Background: Definitive resection of the primary is frequently part of the management of patients (pts) with stage IV rectal cancer with good performance status and low volume of systemic metastases. It is unclear whether delaying systemic therapy for up front surgical management of the primary compromises overall survival (OS). Methods: Pts with metastatic rectal adenocarcinoma who received definitive surgical resection between 1998-2011 were identified in an IRB approved registry. The sequencing of CT and surgery, and the use of perioperative radiation therapy (RT), was at the discretion of treating physicians. Preoperative chemotherapy (Pre-CT) regimens included 5-fluorouracil (5-FU) +/- leukovorin (LV), capecitabine, 5-FU/LV/oxaliplatin +/- avastin, or 5-FU/LV/irinocetan. RT dose was typically 50.4 Gy. OS was measured from the date of diagnosis. Baseline variables were compared using the Chi-square and unpaired t-tests. OS was calculated using the Kaplan Meier method. Univariate (UVA) and multivariate analysis (MVA) were performed using Cox proportional hazards regression to identify variables associated with OS. Results: In this study of 115 pts, 75 (65%) were treated with pre-CT, while 40 (35%) were treated with up front surgery. Of the pts who received surgery up front, 3 (8%) received RT and of the pts who received pre-CT, 62 (83%) received RT. The cohort was predominantly male (70%) with a median age of 57, median KPS of 80, and median follow-up of 24.1 months. 94% of pts had T3/T4 tumors, 80% had N+ disease, and 33% had poorly differentiated tumors. Liver directed therapy (LDT) was performed in 61% of pts. There was no significant difference in OS (32.3 vs. 32 months; p = 0.24) between pts treated with pre-CT and those who received surgery up front, respectively. UVA demonstrated that pre-CT was not associated with OS (HR 1.26; p = 0.544). MVA demonstrated that pts with poorly differentiated tumors (HR 2.04; p = 0.007) and those that did not undergo LDT (HR 2.45; p = 0.001) had inferior survival. Conclusions: Delaying systemic chemotherapy in order to achieve local control with surgical resection up front does not appear to impact OS in pts with stage IV rectal cancer.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 10037-10037
Author(s):  
Akina Natori ◽  
Bryan Anthony Chan ◽  
Hao-Wen Sim ◽  
Lucy Xiaolu Ma ◽  
Daniel Yokom ◽  
...  

10037 Background: The optimal treatment and outcome for elderly patients (pts) with localized gastroesophageal (GE) cancer remains unclear as they are underrepresented in clinical trials. We aimed to assess survival in pts ≥75 years according to treatment received. Methods: A retrospective analysis was performed for all pts aged ≥75 years with GE cancer treated in 2012-2014. Frailty was measured using the Charlson comorbidity index (CCI) and ECOG performance status (PS). Overall survival (OS) and disease-free survival (DFS) were assessed via uni- and multivariable Cox proportional hazards regression, adjusting for demographics. Logistic regression analyses were used to examine factors impacting treatment choices. Results: Of 105 pts, median age was 81 years (range: 75-99), primary sites were esophageal (55%, with 43% squamous histology) and gastric (45%). Baseline characteristics included: PS: 0 (31%), 1 (42%), 2 (16%), 3 (10%), 4 (1%); and CCI: 0 (34%), 1 (25%), 2 (19%), ≥3 (22%). Treatment received included radiotherapy alone (RT) (31%); surgery alone (29%); surgery plus adjuvant chemotherapy (chemo) and/or RT (14%); chemoradiation alone (7%) and supportive care (18%). In univariable analyses; age < 85 (p = 0.003), PS < 2 (p = 0.03) and surgery (p < 0.001) were associated with improved OS. Chemo and RT, either alone or in combination, did not significantly improve OS. In multivariable analyses; surgery (HR 0.38, 95% CI 0.21-0.70, p = 0.002) was the only independent predictor for improved OS. Patients with good PS (p = 0.01), gastric disease site (p = 0.01) and adenocarcinoma histology (p = 0.02) were more likely to undergo surgery. Conclusions: At our institution, relatively few pts ≥75 years received multimodality therapy for localized GE cancers. Those pts ≥75 years who underwent surgery had excellent outcomes, but they were well-selected. Comprehensive assessment should be considered for pts ≥75 years with localized GE cancer to ensure optimal treatment selection, particularly given the potential benefit of surgery.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e16571-e16571
Author(s):  
Kevin Wong ◽  
Michael Shusterman ◽  
Benjamin Adam Gartrell

e16571 Background: Black patientswithrenal cell carcinoma (RCC) have a unique distribution of histological subtypes and historic worse survival compared to white patients. Little is known about RCC in Hispanics. We investigated histologic and survival differences between racial groups treated for RCC at the Montefiore-Einstein Cancer Center (MECC) in Bronx, NY. Methods: We included via the Cancer Registry 1010 patients who underwent RCC resection at MECC between 2000 and 2015. Demographics, clinical characteristics and pathology reports were collected. Logistic regression and Cox proportional hazards models were built to evaluate the association of histology and survival with clinically and statistically significant risk factors in Non-Hispanic White (NHW), Non-Hispanic Black (NHB), and Hispanic (H) patients. Results: 233 patients were NHW (23.1%), 383 NHB (37.9%), 174 H (17.2%), and 220 other race (21.8%). Median age was 61 (range 22, 91). 58% were male. Histology was 529 (52%) clear cell (CC), 255 (25%) papillary (P), 100 (10%) chromophobe, and 126 (12.5%) other. P was more common in NHB (60.5%) compared to NHW (17%) and less common in H (6.3%) patients (P < 0.0001). On multivariate logistic analysis, patients with P vs. CC were more likely to be NHB (OR 5.06; 95% CI 2.92, 8.76; P < 0.0001) and less likely to have a body mass index > 30 (BMI, OR 0.49; 95% CI 0.32, 0.76, P = 0.001) adjusting for age, race, gender, hypertension (HTN), and end stage renal disease (ESRD). Adjusting for above covariates there were no significant differences for C vs. CC. There was no difference in disease free survival (DFS) for NHB vs. NHW (HR 0.93; 95% CI 0.44, 1.94; P = 0.841) or H vs. NHW (HR 1.29; 95% CI 0.62, 2.71; P = 0.495) patients adjusting for age, gender, histology, ESRD, and BMI. There was no difference in overall survival (OS) for NHB vs. NHW (HR 0.97; 95% CI 0.57, 1.65; P = 0.908) or H vs. NHW (HR 1.37; 95% CI 0.79, 2.38; P = 0.256) patients adjusting for the same covariates. Conclusions: In this cohort of patients with RCC, P histology and lower BMI were significantly associated with NHB race. Unlike historic cohorts there was no significant difference in DFS or OS in NHB compared to NHW patients.


2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 364-364
Author(s):  
Matthew Parsons ◽  
Randa Tao ◽  
Shane Lloyd ◽  
Skyler Bryce Johnson ◽  
Courtney L. Scaife ◽  
...  

364 Background: Trimodality therapy with chemoradiation followed by surgery is the standard of care for non-metastatic esophageal cancer. Some patients refuse surgery and this information is captured in the National Cancer Database (NCDB). We sought to understand factors associated with refusal of surgery in these patients and to compare their survival rates with those who undergo surgery. Methods: Data from the NCDB for patients with pathologically proven non-metastatic esophageal cancer from 2006 to 2013 were pooled and screened. Patients with T1N0M0 disease were excluded. Pearson’s chi-squared test and multivariate logistic regression analyses were used to assess the distribution of demographic, clinical, and treatment factors. After propensity-score matching with inverse probability of treatment weighting, overall survival (OS) was compared between patients who refused surgery and those who had surgery using Kaplan Meier analyses and doubly-robust estimation with multivariate Cox proportional hazards modeling. Results: We found 890 of 18,942 patients (4.6%) refused surgery. Older patients, females, those with squamous histology, patients insured by Medicare and those who received radiation therapy (RT) were more likely to refuse. Patients who had N1 disease, high incomes, those who received chemotherapy and those who lived farther from care were more likely to have surgery. The initial 6 month OS was not significantly different between patients who refused surgery and those who had surgery (93.5% vs 95.1% P= 0.064). However, five-year OS was significantly lower in patients who refused (16.4% vs. 38.4% P< .01). This survival decrement was observed uniquely in patients with both adenocarcinoma and squamous cell carcinoma histology. Among those who refused surgery, the OS decrement was mitigated by increasing RT doses. In those who received over 54 Gy of RT, there was no statistical difference in OS between the groups (HR = 0.84, 95% CI 0.65-1.09). Conclusions: We identified a number of patient characteristics that are related to the refusal of surgery in esophageal cancer. Refusal of surgery was related to a decrease in OS in propensity weighted cohorts. This survival decrement may be mitigated by RT in a dose dependent fashion.


1988 ◽  
Vol 6 (8) ◽  
pp. 1254-1263 ◽  
Author(s):  
D Klaassen ◽  
W Shelley ◽  
A Starreveld ◽  
M Kirk ◽  
D Boyes ◽  
...  

Two hundred fifty-seven eligible patients with stage I, IIA "high risk" ovarian carcinoma and IIB, IIIO (disease confined to pelvis), were randomized to either total abdominal radiotherapy (arm A) 2,250 rad in 20 fractions (107 patients), melphalan (arm B) 8 mg/m2/d X 4 every 4 weeks X 18 courses (106 patients), or intraperitoneal chromic phosphate (arm C) 10 to 20 mCi (44 patients). All patients were initially treated with pelvic radiotherapy; arm A, 2,250 rad in ten fractions; and arms B and C, 4,500 rad in 20 fractions. Entry to arm C was discontinued early because of toxicity. In a multifactor analysis using proportional hazards models, no significant difference in survival was observed although there was a marginally significant difference in disease-free survival (P = .015) with arm B being superior to arm A. Stage (P less than .0001), grade (P less than .0001), and histology (P less than .008) were predictors of survival in the multifactor analysis. Performance status, age, and residual disease were significant predictors in the single factor analysis but were not predictive when correction was made for the effects of stage, grade, and histology. Five-year survival rates are 62% for arm A, 61% for arm B, and 66% for arm C. Median duration of follow-up is 8 years. Long-term complications of radiotherapy were seen in 19 patients on arm A, 11 on arm B, and 11 on arm C. Four patients who had received melphalan developed either a myelodysplastic syndrome or acute leukemia. Violations in covering the whole abdominal target volume were correlated with survival.


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