Exploratory analysis of adjuvant chemotherapy effects after preoperative chemoradiotherapy and radical resection for rectal cancer.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 557-557 ◽  
Author(s):  
In Ja Park ◽  
Cathy Eng ◽  
Y. Nancy You ◽  
Scott Kopetz ◽  
Miguel A. Rodriguez-Bigas ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Adjuvant Chemotherapy ◽  
Cox Regression ◽  
Locally Advanced ◽  
Radical Resection ◽  
Preoperative Chemoradiotherapy ◽  
Exploratory Analysis ◽  
Landmark Analysis ◽  
Significant Reversal ◽  
Intermediate Response

557 Background: Evidence regarding adjuvant chemotherapy (CTx) for patients with rectal cancer after preoperative chemoradiotherapy (CXRT) is limited. The aim of study was to explore the relationship between CXRT response and adjuvant CTx for patients with rectal cancer treated by CXRT and radical resection. Methods: We performed a retrospective consecutive cohort study of patients with locally advanced (cStage II-III by EUS, CT, or MRI) rectal carcinoma treated with preoperative CXRT and radical resection, 1993 to 2008. To explore the late effects, we performed a landmark analysis of patients alive without recurrence at 24 months. The duration free from recurrence (FFR) was compared among patients with complete (CR, ypT0N0), intermediate (IR, ypT1-2N0), or poor (PR, ypT3-4 or N+) response according to adjuvant CTx use and type using multivariate Cox regression. Results: A total of 725 patients met criteria and were evaluated. Median follow-up was 69 months (IQR: 39-104 months). 611 patients received adjuvant CTx: 447 with fluoropyrimidine only (FP), and 139 also received oxaliplatin (Ox). Although receipt of adjuvant chemotherapy was not associated with 5-year FFR overall, (HR: 0.91, 95% CI: 0.58-1.43), adjuvant therapy did appear to suggest a benefit in the IR group (HR, 0.49; 95%CI, 0.21-1.19). Adjusted landmark analysis showed that adjuvant CTx was associated with a significant improvement in FFR among the IR patients only (HR, 0.28; 95% CI, 0.08-1.00, P=.04). Among PR patients FP alone did not improve FFR (HR, 1.22; 95% CI, 0.7-2.12) but the addition of Ox was associated with a non-significant reversal in the direction of the effect (HR, 0.53; 95% CI, 0.16-1.79). Conclusions: In this exploratory analysis, the addition of adjuvant FP CTx appeared to favorably affect the duration FFR only for patients with rectal cancer and intermediate response to CXRT followed by radical resection. These data support the investigation of the role for adjuvant fluoropyrimidine therapy among patients with CR or IR and oxaliplatin for PR patients.

Exploratory analysis of adjuvant chemotherapy benefits after preoperative chemoradiotherapy and radical resection for rectal cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 3556-3556
Author(s):  
George J. Chang ◽  
In Ja Park ◽  
Cathy Eng ◽  
Y. Nancy You ◽  
Scott Kopetz ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Adjuvant Chemotherapy ◽  
Cox Regression ◽  
Locally Advanced ◽  
Radical Resection ◽  
Preoperative Chemoradiotherapy ◽  
Exploratory Analysis ◽  
Landmark Analysis ◽  
Significant Reversal ◽  
Intermediate Response

3556 Background: Evidence regarding adjuvant chemotherapy (CTx) for patients with rectal cancer after preoperative chemoradiotherapy (CXRT) is limited. The aim of study was to explore the relationship between CXRT response and adjuvant CTx for patients with rectal cancer treated by CXRT and radical resection. Methods: We performed a retrospective consecutive cohort study of patients with locally advanced (cStage II-III by EUS, CT, or MRI) rectal carcinoma treated with preoperative CXRT and radical resection, 1993 to 2008. To explore the late effects, we performed a landmark analysis of patients alive without recurrence at 24 months. The duration free from recurrence (FFR) was compared among patients with complete (CR, ypT0N0), intermediate (IR, ypT1-2N0), or poor (PR, ypT3-4 or N+) response according to adjuvant CTx use and type using multivariate Cox regression. Results: A total of 725 patients met criteria and were evaluated. Median follow-up was 69 months (IQR: 39-104 months). 611 patients received adjuvant CTx: 447 with fluoropyrimidine only (FP), and 139 also received oxaliplatin (Ox). Although receipt of adjuvant chemotherapy was not associated with 5-year FFR overall, (HR: 0.91, 95% CI: 0.58-1.43), adjuvant therapy did appear to suggest a benefit in the IR group (HR, 0.49; 95%CI, 0.21-1.19). 2-year landmark analysis showed that adjuvant CTx was associated with a significant improvement in FFR among the IR patients only (HR, 0.28; 95% CI, 0.08-1.00, p=0.04). Among PR patients FP alone did not improve FFR (HR, 1.22; 95% CI, 0.7-2.12) but the addition of Ox was associated with a non-significant reversal in the direction of the effect (HR, 0.53; 95% CI, 0.16-1.79). Conclusions: In this exploratory analysis, the addition of adjuvant FP CTx appeared to favorably affect the duration FFR only for patients with rectal cancer and intermediate response to CXRT followed by radical resection. These data support the investigation of the role for adjuvant fluoropyrimidine therapy among patients with CR or IR and the addition of oxaliplatin for PR patients.

What determines adjuvant chemotherapy use after neoadjuvant chemoradiotherapy for rectal cancer?

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 546-546 ◽  
Author(s):  
George J. Chang ◽  
Chung-Yuan Hu ◽  
Y. Nancy You ◽  
Cathy Eng ◽  
Miguel A. Rodriguez-Bigas ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Adjuvant Chemotherapy ◽  
Treatment Guidelines ◽  
Locally Advanced ◽  
Neoadjuvant Chemoradiotherapy ◽  
Radical Resection ◽  
Advanced Rectal Cancer ◽  
Locally Advanced Rectal Cancer ◽  
Clinicopathologic Characteristics ◽  
Treatment Standard

546 Background: The treatment standard for rectal cancer patients after neoadjuvant chemoradiotherapy (CXRT) and radical resection includes adjuvant chemotherapy (CT). The purpose of this study was to evaluate patient demographic and clinicopathologic characteristics in relation to adjuvant CT use. Methods: A retrospective cohort study of patients ≥ 65 years old with rectal cancer treated by neoadjuvant CXRT and radical resection in the Surveillance, Epidemiology, and End Results-linked Medicare database (1998-2007, Medicare Part A/B only) was performed. Multivariate logistic regression was used to assess CT utilization in relation to patient, tumor and treatment response characteristics. Results: Among 1344 patients who met study criteria, 748 (55.6%) received adjuvant CT with 5-fluorouracil (FU) including 189 (25.3%) who also received oxaliplatin (Ox). ypStage was the strongest determinant of both any post-operative CT (43.1% stage I, 51.3% stage II, 73.4% stage III). Other associated factors included age, comorbidity, marital status and surgery type. In addition, age, socioeconomic status, and grade were associated with Ox use. These effects persisted even after exclusion of patients with comorbidities. Conclusions: Although standard treatment guidelines for locally advanced rectal cancer include postoperative CT for all patients after neoadjuvant CXRT and radical resection, nearly 1 in 2 patients failed to receive adjuvant CT. Despite the absence of established evidence, treatment decisions appear to be influenced by the findings at surgical pathology. [Table: see text]

scholarly journals Beware of Early Relapse in Rectal Cancer Patients Treated With Preoperative Chemoradiotherapy

2020 ◽  
Vol 36 (6) ◽  
pp. 382-389
Author(s):  
Seul Gi Oh ◽  
In Ja Park ◽  
Ji-hyun Seo ◽  
Young Il Kim ◽  
Seok-Byung Lim ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Cancer Patients ◽  
Locally Advanced ◽  
Radical Resection ◽  
Late Recurrence ◽  
Preoperative Chemoradiotherapy ◽  
Early Recurrence ◽  
Initial Recurrence ◽  
Recurrence Patterns

Purpose: Recurrence patterns in rectal cancer patients treated with preoperative chemoradiotherapy (PCRT) are needed to evaluate for establishing tailored surveillance protocol.Methods: This study included 2,215 patients with locally-advanced mid and low rectal cancer treated with radical resection between January 2005 and December 2012. Recurrence was evaluated according to receipt of PCRT; PCRT group (n = 1,258) and no-PCRT group (n = 957). Early recurrence occurred within 1 year of surgery and late recurrence after 3 years. The median follow-up duration was 65.7 ± 29 months.Results: The overall recurrence rate was similar between the PCRT and no-PCRT group (25.8% vs. 24.9%, P = 0.622). The most common initial recurrence site was the lungs in both groups (50.6% vs. 49.6%, P = 0.864), followed by the liver, which was more common in the no-PCRT group (22.5% vs. 33.6%, P = 0.004). Most of the recurrence occurred within 3 years after surgery in both groups (85.3% vs. 85.8%, P = 0.862). Early recurrence was more common in the PCRT group than in the no-PCRT group (43.1% vs. 32.4%, P = 0.020). Recurrence within the first 6 months after surgery was significantly higher in the PCRT group than in the no-PCRT group (18.8% vs. 7.6%, P = 0.003). Lung (n = 27, 44.3%) and liver (n = 22, 36.1%) were the frequent the first relapsed site within 6 months after surgery in PCRT group.Conclusion: Early recurrence within the first 1 year after surgery was more common in patients treated with PCRT. This difference would be considered for surveillance protocols and need to be evaluated in further studies.

scholarly journals Association of tumor differentiation and prognosis in patients with rectal cancer undergoing neoadjuvant chemoradiation therapy

2018 ◽  
Vol 7 (4) ◽  
pp. 283-290 ◽  
Author(s):  
Qunsheng Huang ◽  
Huabo Qin ◽  
Jian Xiao ◽  
Xiaosheng He ◽  
Minghao Xie ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Cox Regression ◽  
Locally Advanced ◽  
Radical Resection ◽  
Neoadjuvant Chemoradiation ◽  
Chemoradiation Therapy ◽  
Tumor Differentiation ◽  
Poor Differentiation ◽  
Poorly Differentiated ◽  
Well Differentiated

Abstract Background and objective Neoadjuvant chemoradiation therapy (NCRT) followed by radical resection has been a common practice for patients with locally advanced rectal cancer. This study aimed to analyse the association of tumor differentiation and prognosis in rectal-cancer patients undergoing NCRT. Methods Patients with locally advanced, non-mucinous rectal cancer who underwent NCRT followed by radical resection between 2007 and 2017 were identified from an electronic health record system at the Sixth Affiliated Hospital of Sun Yat-sen University (Guangzhou, China). Multivariable logistic regression and multivariate Cox regression were performed to analyse the association of response to NCRT and survival with clinicopathological characteristics of all these patients. Results We identified 325 patients (241 males and 84 females; mean age, 54.4 ± 11.2 years) who underwent NCRT followed by radical resection, including 26 (8.0%) with poorly-differentiated rectal cancer, 182 (56.0%) with moderately-differentiated cancer and 117 (36.0%) with well differentiated cancer. Propensity score matching analysis and multivariable logistic regression analysis results showed that tumor differentiation was significantly associated with response to NCRT. In the poor differentiation and non-poor differentiation groups, the 3-year overall survival (OS) rates were 74.6 and 93.5%, respectively, whereas the 3-year local recurrence rates were 18.6 and 3.7%, respectively. Multivariable Cox regression analyses revealed that poor differentiation was an independent risk factor for local recurrence and OS. Conclusions Among the patients with locally advanced, non-mucinous rectal cancer, the patients with poorly-differentiated cancer who underwent NCRT had a worse response to NCRT and poorer prognosis than those with moderately- and well-differentiated diseases.

Preoperative chemoradiotherapy and postoperative chemotherapy with 5-fluorouracil and oxaliplatin versus 5-fluorouracil alone in locally advanced rectal cancer: First results of the German CAO/ARO/AIO-04 randomized phase III trial.

2011 ◽  
Vol 29 (18_suppl) ◽  
pp. LBA3505-LBA3505 ◽  
Author(s):  
C. Roedel ◽  
H. Becker ◽  
R. Fietkau ◽  
U. Graeven ◽  
W. Hohenberger ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Adjuvant Chemotherapy ◽  
Primary Endpoint ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Advanced Rectal Cancer ◽  
Preoperative Chemoradiotherapy ◽  
Locally Advanced Rectal Cancer ◽  
Free Survival ◽  
Disease Free

LBA3505 Background: The German CAO/ARO/AIO-94 trial established preoperative chemoradiotherapy (CRT), surgery, and postoperative chemotherapy with 5-FU as standard treatment for locally advanced rectal cancer. With this approach local relapse rates are below 10%. The development of distant metastasis is the predominant mode of failure. Integrating more effective systemic treatment into combined modality therapy was the goal of CAO/ARO/AIO-04. Methods: Between 7/2006-2/2010, patients with rectal cancer within 12 cm from the anal verge and clinical evidence of perirectal fat or lymph node involvement were randomly assigned to receive preoperative CRT, surgery, and adjuvant chemotherapy with 5-FU according to CAO/ARO/AIO-94 (arm 1), or preoperative CRT (50.4 Gy in 28 fractions) with 5-FU (250 mg/m2/days 1-14 and 22-35) and oxaliplatin (50 mg/m2/days 1, 8, 22, 29), surgery, and 8 cycles of adjuvant chemotherapy according to modified FOLFOX6 regimen (arm 2). Disease-free survival was the primary endpoint. We present early secondary endpoints, including acute toxicity, treatment compliance, and pCR-rates. Results: 637 patients were randomly assigned to arm 1 and 628 to arm 2. Full dose preoperative RT and full dose concurrent chemotherapy was delivered in 97% and 74% of patients in both arms, respectively. Preoperative grade 3/4 toxicity occurred in 21.6% in arm 1 and in 22.9% in arm 2. The R0-resection rate was 95.4% in both arms, and abdominoperineal resections were limited to 11.9% and 12.2% in arms 1 and 2, respectively. Overall postoperative complications were not different between both arms (21.0% and 21.9%). The pCR rate (ypT0N0) was 13.1% in arm 1 and 17.6% in arm 2 (p = 0.033, Cochran-Mantel-Haenszel Chi-Squared Test without continuity correction for conditional independence of pCR rate in the two treatment arms in each stratum). Conclusions: Inclusion of oxaliplatin to 5-FU based CRT was well tolerated and associated with increased pCR-rates compared with 5-FU-CRT alone. Longer follow-up is necessary to evaluate the primary endpoint, disease-free survival.

Adjuvant chemotherapy with oxaliplatin/5-fluorouracil/leucovorin (FOLFOX) versus 5-fluorouracil/leucovorin (FL) in patients with locally advanced rectal cancer after preoperative chemoradiotherapy followed by surgery: A randomized phase II study (The ADORE).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 3570-3570 ◽  
Author(s):  
Yong Sang Hong ◽  
Byung-Ho Nam ◽  
Kyung Hae Jung ◽  
Jae-Lyun Lee ◽  
Kyu-Pyo Kim ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Adjuvant Chemotherapy ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Sensory Neuropathy ◽  
Advanced Rectal Cancer ◽  
Preoperative Chemoradiotherapy ◽  
Locally Advanced Rectal Cancer

3570 Background: Preoperative chemoradiotherapy (Pre-CRT) with fluoropyrimidines (Fp) followed by surgery is one of the standard treatments for patients (pts) with locally advanced rectal cancer (LARC); however, the role of adjuvant chemotherapy is still controversial. The aim of this study is to investigate the efficacy of adjuvant FOLFOX for LARC pts who underwent Fp-based Pre-CRT and complete total mesorectal excision (TME). Methods: This randomised phase II study accrued LARC pts whose ypStage was II (ypT3-4/ypN0) or III (any ypT/ypN1-2) after Fp-based Pre-CRT followed by TME. Pts were randomly assigned (1:1) to receive adjuvant chemotherapy either with FL (5-FU 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles) or FOLFOX (oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-FU bolus 400 mg/m2 on D1, 5-FU infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles). The primary endpoint was disease-free survival (DFS). Results: A total of 320 pts were randomly assigned (161 FL and 159 FOLFOX) between November 2008 and June 2012, the arms were balanced. By intent-to-treat analysis, estimated 2-year DFS rate was 82.0% in FOLFOX arm and 69.4% in FL arm (HR 0.46 [95% CI, 0.28-0.76], p=0.002) after the median follow-up duration of 22.5 months. The statistical improvements of DFS were maintained regardless of ypStage: 2-year DFS rate was 89.7% (FOLFOX) vs 76.4% (FL) in pts (n=122) with ypStage II (HR 0.32 [0.10-0.98], p=0.035), and 78.1% (FOLFOX) vs 64.4% (FL) in pts (n=198) with ypStage III (HR 0.49, [0.27-0.86], p=0.011). All grade leucopenia (32% vs 22%), neutropenia (70% vs 46%), thrombocytopenia (26% vs 2%) and sensory neuropathy (71% vs5%) were more frequently observed in FOLFOX arm; however, grade 3/4 adverse events (AE) were not different between arms. Conclusions: Adjuvant FOLFOX improved 2-year DFS relative to FL for LARC pts whose ypStage II or III after Fp-based Pre-CRT followed by TME. Significant AEs were not different between arms. The DFS results will be updated in the presentation. Clinical trial information: NCT00807911.

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