Factors associated with acute toxicity during chemoradiation therapy for rectal cancer.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 734-734
Author(s):  
Pooja Monpara ◽  
Scott Rice ◽  
Talha Shaikh ◽  
Jeffrey M. Farma ◽  
Elin R. Sigurdson ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Weight Loss ◽  
Acute Toxicity ◽  
Performance Status ◽  
Multivariable Analysis ◽  
Rectal Adenocarcinoma ◽  
Factors Associated ◽  
Increased Risk ◽  
Grade 3 ◽  
Experienced Grade

734 Background: Acute toxicity may be a factor interfering with receipt of chemoradiation (CRT) therapy for rectal cancer. The purpose of this study was to identify clinical and treatment factors associated with increased acute toxicity in patients receiving CRT therapy for rectal cancer. Methods: We identified patients with rectal adenocarcinoma treated with CRT between 2006-2014 at an NCI-designated cancer center. Patients with metastatic disease or missing treatment information were excluded. Acute toxicity information including weight loss, pain, fatigue, constipation, diarrhea, anorexia, and performance status was extracted from weekly on treatment visit notes. Multivariable logistic regression was used to assess predictors of grade 3+ toxicity using covariates significant on univariable analysis. Results: A total of 148 patients were included with a median age of 59 (range 29-99). The majority of patients were male (55%) and received 5-FU based chemotherapy (82%). During CRT, 35 (24%) patients experienced at least one grade 3+ toxicity: 13 (9%) patients experienced grade 3+ fatigue, 1 (1%) experienced grade 3+ constipation, 11 (7%) experienced grade 3+ diarrhea, 14 (10%) experienced grade 3+ pain, and 11 (7%) experienced grade 3+ anorexia. Eight (5.4%) patients had an ECOG performance status > 3 and 28 (19%) patients had weight loss > 5 lbs during CRT. On multivariable analysis, increased distance from the anal verge (OR 0.78 95% CI 0.636-0.998) was associated with a decreased risk for grade 3+ pain and age > 75 was associated with an increased risk of grade 3+ anorexia (OR 6.07 95% CI 1.067-34.56). Clinical T4 disease was associated with an increased risk of weight loss > 5 lbs (OR 0.17 95% CI 0.100-0.446). On multivariable analysis, there were no factors associated with grade 3+ fatigue, diarrhea, or constipation. There were no factors associated with a decline in performance status to > 3 while on treatment. Conclusions: Our results suggest that rectal cancer patients who are older, have more advanced disease, or with low lying tumors may be at an increased risk for treatment-related toxicity. Identifying predictors of toxicity may allow for tailored interventions to minimize toxicity for these patients.

Capecitabine and oxaliplatin as induction and concomitant with radiotherapy in rectal cancer: A phase II study.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 604-604
Author(s):  
J. A. Gutierrez ◽  
G. Martinez-Martinez ◽  
A. J. Silva ◽  
J. Gomez Rangel ◽  
M. Palmerin ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Performance Status ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Complete Response ◽  
Induction Treatment ◽  
Ecog Performance Status ◽  
Dermatologic Toxicity ◽  
Grade 3 ◽  
Experienced Grade

604 Background: Preoperative combined modality chemoradiation with fluoropyrimidine-based schedules is widely accepted as the current standard of care for localized rectal cancer. Current strategies have focused on intensifying the neoadjuvant systemic treatment to improve pCR. Methods: From January 2009 to January 2010, 18 patients with locally advanced rectal cancer (T3, any N, M0) were included according to Simon's design. Treatment was 2 cycles of capecitabine 1000 mg/m2 bid (D1-14) and oxaliplatin 85 mg/m2 (D1) every 3 weeks as induction followed by chemoradiation (45 Gy). During radiotherapy patients received 2 cycles of capecitabine 750 mg/m2 bid (D1-14) and oxaliplatin 85 mg/m2 (D1 and 8) every 3 weeks. Surgery was planned 5-10 weeks after completion of radiotherapy. The primary endpoint was pCR. Results: 18 patients were assessable for response. Median age was 55 y (41-65), 11 patients with ECOG performance status of 1 (61%), all 18 patients were staged as T3, 10 were staged N+ (56%). Of the 18 patients, 17 patients were given CRT and 13 patients (76%) underwent radical resection. Of the patients who did not underwent resection, 1 patient was considered unresectable at the time of surgery, 2 patients refused surgery because of clinical complete response and 1 patient experienced progressive disease to the spine after chemoradiation. During induction treatment 1 patient (6%) experienced grade 3-4 toxicity (diarrhea). During chemoradiation 1 patient (6%) experienced grade 3 diarrhea and nausea and 1 patient (6%) experienced grade 3 radio-induced dermatologic toxicity; overall grade 3-4 toxicity of 12%. No grade 4 toxicity or treatment related deaths were observed. Of the 13 patients who underwent resection, 12 patients (92%) had a complete resection (R0). Pathologic complete response rate was observed in 1 patient (6%) according to intent to treat. The study was closed after the first stage because it did not reach the minimum required number of pCR. Conclusions: Induction chemotherapy with capecitabine and oxaliplatin before chemoradiation is feasible. Given that we did not reach the prespecified pCR rate required to continue the trial, the study was closed after the first stage. No significant financial relationships to disclose.

Factors associated with survival in non-small cell lung cancer (NSCLC) patients with a solitary metastasis.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e19121-e19121
Author(s):  
Ravi Parikh ◽  
Angel Cronin ◽  
David E. Kozono ◽  
Geoffrey R. Oxnard ◽  
Raymond H. Mak ◽  
...  
Keyword(s):  
Overall Survival ◽  
Weight Loss ◽  
Performance Status ◽  
Multivariable Analysis ◽  
Local Therapy ◽  
Stage Iv ◽  
Metastatic Lesion ◽  
Factors Associated ◽  
N Stage ◽  
The Impact

e19121 Background: Although palliative chemotherapy is the standard of care for metastatic NSCLC, somepatients with oligometastatic disease may benefit from aggressive local therapy. We investigated factors associated with greater survival among patients diagnosed with a solitary metastatic lesion. Methods: We identified patients diagnosed with stage IV NSCLC who presented with a solitary metastatic lesion based on PET and MRI and who were prospectively consented and enrolled in our institutional database from 2002-2011. Univariable and multivariable Cox proportional hazards models were used to analyze factors associated with overall survival among this cohort. Results: We identified 110 patients (10.7% of stage IV patients) meeting our inclusion criteria. Median age at diagnosis was 61 years, 50% of patients were female, 66% had adenocarcinoma histology, and 35% had N0-1 disease. Median survival from diagnosis was 18.7 months, with a median followup of 31.5 months. On univariable analysis, greater overall survival was associated with ECOG performance status 0-1 vs 2+ (median 21.5 months vs 12.6 months, HR 0.32, p<0.01); weight loss <2 vs >2 kg (22.4 vs 13.8, HR 0.56, p=0.03); and N stage 0-1 vs 2-3 (32.0 vs 17.6, HR 0.52, p=0.02). Adenocarcinoma vs non-adenocarcinoma histology (22.9 vs 13.8, HR 0.65, p=0.07) was borderline significant. Age, gender, race, current smoking, size of primary tumor, and metastatic organ were not significantly associated with survival. On multivariable analysis, adenocarcinoma histology (HR= 0.58, p=0.06); N stage 0-1 (HR= 0.43, p=0.01); and weight loss <2 kg (HR 0.53, p=0.03) were associated with greater overall survival. Conclusions: Select patient and tumor characteristics may predict for improved survival among patients with oligometastatic NSCLC. Future studies will evaluate the impact of aggressive local therapy in these patients.

The association of age with acute toxicities in NRG oncology combined modality lower GI cancer trials.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 649-649 ◽  
Author(s):  
Noam Avraham VanderWalde ◽  
Jennifer Moughan ◽  
Stuart M. Lichtman ◽  
Reshma Jagsi ◽  
Matthew T. Ballo ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Older Patients ◽  
Combined Modality Therapy ◽  
Performance Status ◽  
Univariate Analysis ◽  
Multivariable Analysis ◽  
Categorical Variables ◽  
P Value ◽  
Combined Modality ◽  
Grade 3

649 Background: This study sought to compare adverse events (AEs) of older and younger adults with lower gastrointestinal (GI) malignancies treated on NRG studies. Methods: Data from six NRG trials (RTOG 9811/0012/0247/0529/0822 & NSABP R-04), testing combined modality therapy (radiation and chemotherapy) in patients with anal or rectal cancer, were collected to test the hypothesis that older age was associated with increase in acute ( ≤ 90 days from treatment start) AEs. AEs were defined as GI, Genitourinary (GU), hematologic, or skin. AEs and compliance with protocol-directed therapy were compared between patients aged ≥ 70 years and < 70 years. Categorical variables were compared across age groups using the chi-square test. The association of age on AEs was evaluated using a covariate-adjusted logistic regression model, with odds ratio (OR) reported. To adjust for multiple comparisons, a p-value < 0.01 was considered statistically significant. Results: Data from 2525 patients were collected (43% female, 72% rectal cancer). There were 380 patients ≥ 70 years old (15%). Older patients were more likely to have worse baseline performance status (PS 1 or 2) (23% vs. 16%, p <0.01), but otherwise baseline characteristics were similar. Older patients were less likely to have completed their chemotherapy (78% vs. 87%, p < 0.01), but had similar median RT duration. On univariate analysis, patients ≥ 70 were more likely to experience grade ≥ 3 GI AEs (36% vs. 23%, OR 1.82, p < 0.001), and less likely to experience ≥ 3 skin AEs (8% vs. 14%, OR 0.56, p = 0.002). There was no difference between GU or hematologic AEs. On multivariable analysis, age ≥ 70 was associated with grade ≥ 3 GI AE (OR 1.80, 95% CI: 1.40, 2.31; p < 0.001) after adjusting for gender, PS, T stage, disease site, RT duration, and chemotherapy completion. Conclusions: Older patients with curable lower GI cancers who underwent combined-modality therapy were less likely to complete chemotherapy and were more likely to experience serious GI toxicity, whereas younger patients had higher rates of serious skin AEs.

Efficacy and safety of surgery for spontaneous pneumothorax in elderly patients

2019 ◽  
Author(s):  
Shunichi Nagata ◽  
Mitsugu Omasa ◽  
Kosuke Tokushige ◽  
Takao Nakanishi ◽  
Hideki Motoyama
Keyword(s):  
Risk Factors ◽  
Surgical Treatment ◽  
Postoperative Complications ◽  
Elderly Patients ◽  
Spontaneous Pneumothorax ◽  
Performance Status ◽  
Multivariable Analysis ◽  
Efficacy And Safety ◽  
Air Leaks ◽  
Grade 3

Abstract OBJECTIVES There is no clear consensus on the surgical indications for spontaneous pneumothorax in elderly patients. In this study, we aimed to assess the efficacy and safety of surgical treatment of spontaneous pneumothorax in patients aged ≥70 years. We also sought to identify the risk factors for postoperative prolonged air leaks and complications in such patients. METHODS Data pertaining to 104 elderly patients who underwent surgery out of 206 patients (aged ≥70 years) who were diagnosed with spontaneous pneumothorax at our institution between 1994 and 2018 were retrospectively reviewed. The incidences of postoperative persistent air leaks (≥2 days) and postoperative complications (≥grade 3; Clavien–Dindo classification) were analysed for efficacy and safety assessment, respectively. RESULTS Median postoperative air leaks continued for 0 days (range 0–25); 14.4% patients developed ≥grade 3 postoperative complications. On the basis of results of multivariable analysis, it was observed that a higher PaCO2 level was significantly associated with prolonged postoperative air leaks [odds ratio (OR) 1.08, 95% confidence interval (CI) 1.00–1.17; P = 0.047]. Poorer performance status was associated with a significantly increased risk of postoperative complications, as assessed by multivariable analysis (OR 6.13, 95% CI 1.38–27.3; P = 0.017). The recurrence rate was 4.8%; mortality rate of patients was 2.9%. Three-year survival rate after surgery was 73.8%. CONCLUSIONS Surgical treatment of spontaneous pneumothorax may be effective and safe in selected elderly patients. Moreover, higher PaCO2 and poorer performance status were independent risk factors for postoperative persistent air leaks and complications, respectively.

Risk Associated with Severe Hematological Toxicity in Patients with Urothelial Cancer Receiving Combination Chemotherapy of Gemcitabine and Cisplatin

Chemotherapy ◽  
2020 ◽  
Vol 65 (1-2) ◽  
pp. 29-34
Author(s):  
Noriko Takahashi ◽  
Tomiko Sunaga ◽  
Tatsuhiro Fujimiya ◽  
Tatsuya Kurihara ◽  
Akiko Nagatani ◽  
...  
Keyword(s):  
Risk Factors ◽  
Neutrophil Count ◽  
Combination Chemotherapy ◽  
Urothelial Cancer ◽  
Performance Status ◽  
Hematological Toxicity ◽  
Toxicity Risk ◽  
Grade 3 ◽  
Experienced Grade ◽  
Gemcitabine And Cisplatin

Introduction: Combination chemotherapy of gemcitabine and cisplatin (GC) is the standard treatment for patients with urothelial cancer (UC). However, hematological toxicity is a major side effect of GC therapy in patients with UC. In particular, discontinuation of the GC therapy is associated to adverse events such as hematological toxicity. Some studies have reported general risk factors of hematological toxicity such as age. However, little is known about risk factors for GC therapy-associated hematological toxicity in patients with UC. Objective: We aimed to identify risk factors for hematological toxicity in patients with UC receiving GC therapy. Methods: We performed a retrospective evaluation of the data of 128 patients with UC who received GC therapy. The study end point was defined as the occurrence of grade 4 neutropenia and grade ≥3 thrombocytopenia. Logistic regression analysis was used to determine risk factors that were significantly associated with neutropenia and thrombocytopenia. Results: In total, 62 (48.4%) patients experienced grade 4 neutropenia, and 27 (21.1%) patients experienced grade ≥3 thrombocytopenia. In the multivariate analysis, performance status (PS) ≥1 (odds ratio [OR] 3.764, 95% confidence interval [CI] 1.410–10.047, p = 0.008) and neutrophil count (OR 0.648, 95% CI 0.468–0.898, p = 0.009) were significantly associated with grade 4 neutropenia. Platelet count (PLT) (OR 0.896, 95% CI 0.832–0.966, p = 0.004) and potassium (K) level (OR 6.966, 95% CI 1.313–36.989, p = 0.023) were also significantly associated with grade ≥3 thrombocytopenia. Conclusions: PS ≥ 1, neutrophil count, PLT, and K level were important risk factors for GC therapy-induced hematological toxicity in patients with UC. To continue GC therapy, further management systems by hematological toxicity risk factors for patients with UC will be required.

A cause-specific hazard rate analysis of prognostic factors among 199 adults with acute lymphoblastic leukemia: the Memorial Hospital experience since 1969.

1988 ◽  
Vol 6 (6) ◽  
pp. 1014-1030 ◽  
Author(s):  
J Gaynor ◽  
D Chapman ◽  
C Little ◽  
S McKenzie ◽  
W Miller ◽  
...  
Keyword(s):  
Weight Loss ◽  
Prognostic Factors ◽  
Acute Lymphoblastic Leukemia ◽  
Hazard Rate ◽  
Lymphoblastic Leukemia ◽  
Performance Status ◽  
Factors Associated ◽  
Rate Analysis ◽  
Resistant Disease ◽  
Cause Specific Hazard Rate

Results of a multivariable analysis of prognostic factors are reported for 199 previously untreated adults with acute lymphoblastic leukemia (ALL). These patients have long-term follow-up, and the probability of cure is estimated at approximately 35%. The cause-specific hazard rate analysis found lower rates of achieving complete remission (CR) in patients with WBC greater than 10,000/microL, AUL (undifferentiated) morphology, and older age. Since these patients required additional time to respond, fewer of them actually achieved CR. Characteristics directly associated with a higher rate of death during induction therapy due to severe bone marrow suppression were low serum albumin concentration (less than or equal to 3.5 g/dL), age greater than 50 years, acute undifferentiated leukemia (AUL) morphology, low Karnofsky performance status, and weight loss greater than 5%. Factors associated with a higher rate of relapse were WBC greater than 20,000/microL, non-T cell ALL, age greater than 60 years, Ph' + ALL, and time to achieve CR greater than 5 weeks. These criteria were used to identify patients at high risk of relapse. In addition, the predictive value of high WBC was found to disappear by 18 months of continuous CR. Finally, the rate of death following first relapse was higher in patients with a short first remission duration, high percentage weight loss at initial diagnosis, and older age. In summary, factors associated with a higher rate of death during attempted induction (ie, low albumin, high percent weight loss, and poor performance status) had no association with the patient's ability to remain relapse-free. Conversely, factors correlating with more extensive or resistant disease (ie, high WBC, null or B cell ALL, or Ph' + ALL) showed no association with the ability to tolerate therapy. Thus, a less toxic but more effective induction regimen is needed for patients with a poor clinical status, whereas a more intensive form of therapy appears warranted for patients presenting with more extensive or resistant disease.

Phase II trial of oral gimatecan in adults with recurrent glioblastoma

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 2009-2009
Author(s):  
J. Hu ◽  
P. Y. Wen ◽  
L. E. Abrey ◽  
C. Fadul ◽  
J. Drappatz ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
Performance Status ◽  
Single Agent ◽  
Recurrent Glioblastoma ◽  
Hematologic Toxicity ◽  
Radiographic Response ◽  
Daily Dose ◽  
Grade 3 ◽  
Experienced Grade

2009 Background: Gimatecan is a highly lipophilic oral camptothecin analogue with impressive preclinical activity in glioma models. Methods: We conducted a multicenter two-stage phase II trial to evaluate the efficacy of gimatecan in adults with recurrent glioblastoma. Eligibility criteria included ≤1 prior treatment for recurrent disease, age ≥18, ECOG performance status 0 or 1, and normal organ function. Patients taking enzyme-inducing anti-seizure medications were excluded. Gimatecan 1.22 mg/m2 was given orally once daily for 5 consecutive days during each 28-day cycle. Radiographic response was evaluated by MRI after every second cycle. The primary endpoint of the study was 6 months PFS. A Simon's 2-stage design was used in which 19 patients were evaluated in the first stage, with an additional 36 patients accrued if > 4 patients in stage 1 achieved 6 month PFS. Results: A total of 29 patients were enrolled in the study, with median age of 58 years (range, 25–77 years); 58.6% female; all of whom had received prior surgery, radiation therapy, and at least one regimen of chemotherapy. The daily dose was reduced to 1.0 mg/m2 after four of the first 10 patients experienced grade 4 hematologic toxicity. One patient was removed from trial due to toxicity (grade 3 leukopenia and thrombocytopenia). Treatment delay occurred in 11 patients (38%) and dose reduction was necessary in eight patients (28%). Treatment-related grade 3/4 toxicities included thrombocytopenia (17.2%), leukopenia (17.2%), and neutropenia (10.3%). Only 1/19 patients treated with 1.0 mg/m2/day experienced grade 3/4 hematologic toxicity. The 18% reduction in the daily dose resulted in a 19% decrease in the concentration of total gimatecan in plasma prior to administration of the fifth daily dose (56 ± 23 vs. 45 ± 20 ng/mL) and a 33% decrease in the AUC for dose 5 (8.0±4.8 vs. 5.3±4.2 ng*h/mL). Only one patient had a partial radiographic response by the modified Macdonald criteria and stable disease was the best response in 13 patients. All other patients had progressive disease after two cycles of therapy. Only three patients (12%) were progression-free at 6 months. Median time to progression was 12.0 weeks (95% CI: 7.0, 17.0). Conclusions: Treatment with single-agent gimatecan 1.0 mg/m2/day for 5 days, repeated every 28-days showed minimal efficacy. [Table: see text]

EXPERT-C: A randomized phase II European multicenter trial of neoadjuvant chemotherapy (capecitabine/oxaliplatin) and chemoradiation (CRT) with or without cetuximab followed by total mesorectal excision (TME) in patients with MRI-defined high-risk rectal cancer.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 360-360 ◽  
Author(s):  
A. Dewdney ◽  
D. Cunningham ◽  
J. Tabernero ◽  
B. Glimelius ◽  
A. Cervantes ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
High Risk ◽  
Neoadjuvant Chemotherapy ◽  
Performance Status ◽  
Rectal Adenocarcinoma ◽  
Complete Response ◽  
R0 Resection ◽  
Wild Type ◽  
Braf Mutations ◽  
Secondary Endpoints

360 Background: We previously demonstrated the feasibility of administering neoadjuvant chemotherapy before CRT and TME in patients with MRI selected poor prognosis rectal cancer (Chua Y J et al Lancet Oncol 2010). This trial evaluates the addition of the anti-EGFR antibody cetuximab to this treatment strategy. KRAS and BRAF mutations have been established as predictive for lack of response to anti-EGFR therapy in metastatic colorectal cancer. Methods: Patients with newly diagnosed, histologically confirmed, MRI defined high risk rectal adenocarcinoma were randomised to receive 4 cycles of capecitabine 1,700mg/m2 with oxaliplatin 130mg/m2 (CAPOX) followed by CRT, 45Gy/25# + 5.4Gy/3# boost with concurrent continuous capecitabine 1,650mg/m2/day, TME and 4 cycles of adjuvant CAPOX (EXPERT) or the same regimen with the addition of cetuximab (400mg/m2 loading dose week 1, followed by 250mg/m2/week) (EXPERT-C). The primary endpoint is complete response (CR) (defined as pathological complete response or radiological complete response in patients who decline surgery) in KRAS and BRAF wild type tumours. Secondary endpoints include radiological response to CRT, CR in both KRAS wild type and mutant patients, R0 resection rates, progression free and overall survival and safety. Results: Between 2005-2008, 165 eligible patients were recruited from 15 centres (EXPERT n=81, EXPERT-C n=84). 99% of patients had performance status 0-1, 98% had ≥ T3 disease, 56% had an involved or threatened circumferential resection margin and 72% had evidence of extramural venous invasion determined by MRI. The current median follow up is 30 months. 72/81 (89%) and 79/84 (94%) of patients completed neoadjuvant CRT and 72/81 (89%) and 77/84 (92%) patients underwent curative-intent surgery on the EXPERT and EXPERT-C arms respectively. Two patients declined surgery. Conclusions: The primary and secondary endpoints will be analyzed in October 2010 and will be presented at the meeting. [Table: see text]

A single-institution phase II trial of five fractions of radiotherapy followed by four courses of FOLFOX chemotherapy as preoperative therapy for rectal adenocarcinoma.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 553-553 ◽  
Author(s):  
Robert J. Myerson ◽  
Parag J Parikh ◽  
Benjamin Tan ◽  
Steven Hunt ◽  
James W Fleshman ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Residual Disease ◽  
Rectal Adenocarcinoma ◽  
Standard Of Care ◽  
Response Rates ◽  
Cytotoxic Agents ◽  
Preoperative Treatment ◽  
Local Response ◽  
Grade 3 ◽  
Folfox Chemotherapy

553 Background: Preoperative radiotherapy (RT) with 5FU chemotherapy (CT) is a standard of care for cT3-4 rectal cancer. Studies incorporating additional cytotoxic agents have resulted in increased morbidity with little benefit. We evaluate a template that seeks to (1) include the known benefits of preoperative RT on local response/control, (2) provide for preoperative multi-drug CT, (3) avoid the morbidity of concurrent RT and multi-drug CT. Methods: Patients with cT3-4, any N, any M rectal cancer were eligible. Patients were confirmed to be candidates for surgery, provided the response was sufficient. Preoperative treatment was 5 fractions RT (25 Gy to involved mesorectum, 20 Gy to elective nodes), followed by 4 cycles of mFOLFOX6. Postoperative CT was at the discretion of the medical oncologist. The principal objectives are to demonstrate that this regimen can achieve T stage down staging (ypT < cT) and acute grade 3+ gastrointestinal (GI) morbidity equal to or better than historical controls. Results: Accrual opened late 2009, with 60 patients enrolled through 8/2011. Forty-six have had sufficient time to proceed to surgery with 4 having grade 3 preoperative GI morbidity. Two cases are inevaluable for response: one withdrew consent prior to CT and one received no surgery due to progression of cM1 disease (with local response). The 44 evaluable cases included 4 cT4 and 40 cT3; 32 (73%) cN+, 4 cM1. At surgery 33 (75%) had ypT0-2 residual disease including 13 (30%) ypT0, 14 (32%) were ypN+. Cases were sub-analyzed by whether disease was too advanced for the upcoming ACOSOG preoperative FOLFOX vs. 5FU-RT trial. By ACOSOG eligibility, response rates were (eligible first, ineligible second) ypT0: 10/22 (45%) vs. 3/22 (14%) (p = 0.05), ypT0-2: 19/22 (86%) vs. 14/22 (64%) (p = NS). Conclusions: This regimen achieves high response rates with acceptable morbidity. The response for ACOSOG eligible cases meets pre-determined stopping criteria for proceeding to a randomized trial. Our successor study will randomize to this regimen vs. FOLFOX alone for ACOSOG eligible cases, while initially continuing as a single arm trial for ACOSOG ineligible cases.

Influence of age on chemoradiotherapy outcome in patients with rectal cancer: Exploratory analysis from the phase III study ACCORD 12/0405 PRODIGE 2.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 550-550
Author(s):  
Eric Francois ◽  
David Azria ◽  
Sophie Gourgou-Bourgade ◽  
Isabelle Martel-Lafay ◽  
Christophe Hennequin ◽  
...  
Keyword(s):  
Tumor Regression ◽  
Performance Status ◽  
Locally Advanced ◽  
Rectal Adenocarcinoma ◽  
Pathologic Response ◽  
Exploratory Analysis ◽  
Phase Iii ◽  
Combined Modality Treatment ◽  
Complete Pathologic Response ◽  
Increased Risk

550 Background: Preoperative radiochemotherapy (RCT) is the standard of care for patients (pts) with locally advanced rectal adenocarcinoma. However elderly pts may have an increased risk of adverse events after combined modality treatment. The randomized trial ACCORD 12/0405 PRODIGE 2 compared 5 weeks of treatment with radiotherapy 45 Gy/25 fractions (f) with concurrent capecitabine 800 mg/m² twice daily 5 days per week (Cap 45) or radiotherapy 50 Gy/25 f with capecitabine 800 mg/m2 twice daily, 5 days per week and oxaliplatin 50 mg/m2 once weekly (Capox 50), results of efficacy (complete pathologic response) were not different between the two arms. We analyzed the results of RCT according to pts age. Methods: All eligible pts (n=584) were included in this exploratory analysis. Pts were divided in 2 groups: <70 y and ≥70 y. Toxicity and tumor regression scores were compared between the 2 groups. Results: 442 pts were <70 y and 142 were ≥70 y. Pts characteristics were well balanced between groups (gender, ECOG performance status, primary tumor, histology). Tolerance was worse in pts ≥70 y as shown in the table. Surgical procedures were not different between the 2 groups. Results on histological response were similar between the 2 groups: complete pathologic response was 16.9% (95% CI 13.1 to 20.2%) for pts <70 y and 14.7% (95% CI 9.2 to 21.8%) for pts ≥70 y, (p=0.55) and rates of R0 surgery for pts < 70 y and pts ≥ 70 y were respectively: 90.6% and 88.2%, (p=0.54). Conclusions: As tolerance of elderly pts treated with preoperative RTCT is worse than in younger pts, appropriate therapeutic schedule are warranted for these pts. [Table: see text]

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