scholarly journals Quality of Life in a Randomized Trial Comparing Two Neoadjuvant Regimens for Locally Advanced Rectal Cancer – INCAGI004.

2021 ◽  
Author(s):  
Rodrigo Otavio de Castro Araujo ◽  
Fernando Meton Vieira ◽  
Ana Paula Victorino Ornellas ◽  
Claudia Carrada Torres ◽  
Ivanir Martins ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Rectal Resection ◽  
Locally Advanced ◽  
Advanced Rectal Cancer ◽  
Locally Advanced Rectal Cancer ◽  
Sphincter Preservation ◽  
Treatment Groups ◽  
Group 2 ◽  
Group 1

Abstract Background: Neoadjuvant chemoradiotherapy (neoCRT) followed by surgery is the standard of care for locally advanced rectal cancer (LARC), but the emergence of different drug regimens may result in different response rates. Good clinical response translates into greater sphincter preservation, but quality of life (QOL) may be impaired after treatment due to chemoradiotherapy and surgical side effects. Objective: To prospectively evaluate the QOL in a randomized trial comparing two neoadjuvant regimens for locally advanced rectal cancer.Methods: Stage II and III rectal cancer patients were randomized to receive neoCRT with either capecitabine (Group 1) or 5-Fu and leucovorin (Group 2) concomitant to long course radiotherapy. Clinical downstaging was accessed using MRI 6-8 weeks after treatment. EORTCs QLQ C30 and CR38 were applied before treatment (T0), after neoCRT (T1), after rectal resection (T2), early after adjuvant chemotherapy (T3), and one year after end of treatment or stoma closure (T4). Wexner scale was used for continence evaluation at T4. A C30SummaryScore (Geisinger et cols) was calculated to compare QOL results. Results: 32 patients were assigned to Group 1 and 31 to Group 2. Clinical downstaging occurred in 70.0% of Group 1 and 53.3% of Group 2 (p=0.288). pCR was 23.3% in group 1 and 10.0% in Group 2(p=0.165). Sphincter preservation was 83.3% in Group 1 and 80.0% in Group 2(p=0.111). No difference in QOL was detected comparing the two treatment groups before and after neoCRT. C30SummaryScore detected improvement comparing T0 to T1 and deterioration comparing T1 to T2 (p=0.025), and global health status improved at T1 and T4 compared to T0(p=0.004). Mean Wexner scale score was 9.2, and a high score correlated with symptoms of diarrhea and defecation problems at T4.Conclusions: Clinical and pathological response rates were equivalent in both treatment groups. QOL was improved after neoCRT corresponding to clinical response but decreased following rectal resection. Wexner score was high after sphincter preservation. C30SummaryScore was a useful tool to detect differences in overall QOL in EORTCs multiple item questionnaire.Trial registration: NCT03428529. Registered 02/09/2018 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03428529.

Quality Of Life Using A Summary Score After Neoadjuvant Treatment And Surgery For Rectal Cancer.

2020 ◽  
Author(s):  
Rodrigo Otavio de Castro Araujo ◽  
Fernando Meton Vieira ◽  
Ana Paula Ornellas ◽  
Claudia Carrada Torres ◽  
Ivanir Martins ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rectal Cancer ◽  
Rectal Resection ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Neoadjuvant Chemoradiotherapy ◽  
Sphincter Preservation ◽  
Summary Score ◽  
Group 2

Abstract Introduction :Neoadjuvant chemoradiotherapy (neoCRT) followed by surgery is the standard of care for locally advanced rectal cancer (LARC), and sphincter preservation is a desirable endpoint, but quality of life (QOL) is often impaired after treatment. Objective To evaluate QOL in five different moments of treatment in a randomized trial comparing two different neoadjuvant regimens. Methods Stage II and III rectal cancer patients were randomized to receive neoCRT with either capecitabine (Group 1) or 5-Fu and leucovorin (Group 2) concomitant to long course radiotherapy. EORTCs QLQ C30 and CR38 were applied before treatment (T0), after neoCRT (T1), after rectal resection (T2), early after adjuvant chemotherapy (T3), and one year after end of treatment or stoma closure (T4). Wexner scale was used for continence evaluation at T4. A C30 summary score (Geisinger et cols) was calculated to compare QOL results.Results 32 patients were assigned to Group 1and 31 to Group 2. QOL was improved comparing T0 to T1 (mean 80.5 vs 88.0, p<0.001), and decreased comparing T1 to T2 (mean 88.0 vs 80.4, p<0.001). No difference in QOL summary was detected comparing T2 to T3 (79.8 vs 82.4, p=0.194) or T3 to T4 (83.0 vs 83.0, p=0.993). No difference in QOL was detected comparing the two treatment groups as clinical response was comparable. Mean Wexner scale score was 9.2, and a score ≥10 correlated with symptoms of diarrhea and defecation problems at T4. Conclusion : QOL improved after neoCRT but worsened following rectal resection, with no significant recovery during follow-up. Capecitabine and 5-Fu/Lv were equivalent in neoadjuvant regimen. Incontinence was high after sphincter preservation. C30 summary score was useful to detect differences in overall Quality of Life in addition to C30 multiple item questionnaire.

scholarly journals Neoadjuvant chemotherapy in the combination treatment for locally advanced rectal cancer: currently available options

2018 ◽  
Vol 8 (3) ◽  
pp. 36-41
Author(s):  
D. V. Kuzmichev ◽  
Z. Z. Mamedli ◽  
A. V. Polynovskiy ◽  
Zh. M. Madyarov ◽  
S. I. Tkachev ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Locally Advanced ◽  
Advanced Rectal Cancer ◽  
Locally Advanced Rectal Cancer ◽  
Complete Clinical Response ◽  
Consolidation Chemotherapy ◽  
Group 3 ◽  
Group 2 ◽  
Grade Iii ◽  
Group 1

Objective:to analyze treatment outcomes in patients with locally advanced rectal cancer that received various combinations of neoadjuvant chemotherapy and chemoradiotherapy.Materials and methods. In this retrospective study, we analyzed a cohort of prospectively recruited patients with stage mrT3(CRM+)/ T4N0–2M0 locally advanced rectal cancer. Participants were divided into three groups. Patients in Group 1 received preoperative longcourse radiotherapy given concurrently with capecitabine, followed by 2–6 cycles of consolidation chemotherapy with capecitabine and oxaliplatin (CapOx). In Group 2, patients initially received 1–2 cycles of induction chemotherapy with CapOx, followed by radiotherapy + capecitabine, and then consolidation chemotherapy with CapOx (“sandwich” method). Participants in Group 3 were treated with 1–3 cycles of induction CapOx chemotherapy with subsequent long-course chemoradiotherapy. After the combination treatment, all patients underwent surgery. The primary endpoint of this study was therapeutic pathomorphosis. Secondary endpoints included complete clinical response, toxicity, local recurrence, distant metastasis, and relapse-free survival.Results.This study included 155 patients (98 in Group 1, 44 in Group 2, and 13 in Group 3). Grade III toxicity was documented in 6.12 %, 4.55 %, and 23.08 % of cases in Groups 1, 2, and 3 respectively. None of the patients had grade IV toxicity. Grade III therapeutic pathomorphosis was achieved in 33.7 %, 22.7 %, and 23.1 % of patients in Groups 1, 2, and 3 respectively. Grade IV therapeutic pathomorphosis was observed in 14.3 %, 15.9 %, and 7.69 % of patients in Groups 1, 2, and 3 respectively. Complete clinical response was registered in 16.3 %, 11.4 %, and 0 % of cases in Groups 1, 2, and 3 respectively. Median follow-up was 47.2 months with no signs of progression. Relapses were observed in 1.02 % and 2.27 % of patients from Group 1 and Group 2 respectively, whereas Group 3 demonstrated no relapses. A total of 11.22 %, 13.64 %, and 23.1 % of participants from Groups 1, 2, and 3 respectively developed distant metastasis.Conclusion.Polychemotherapy used within the consolidation and «sandwich» treatment regimens is a promising option for the treatment of locally advanced rectal cancer. The efficacy of induction chemotherapy should be further studied with a larger sample.

Clinical downstaging and quality of life after neoadjuvant chemotherapy in patients with locally advanced rectal cancer: Interim analysis from a phase II clinical trial.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e15178-e15178
Author(s):  
Ahmed Abdalla ◽  
Amr M. Aref ◽  
Amer Alame ◽  
Danny Ma ◽  
Mohammed Barawi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Rectal Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Phase Ii ◽  
General Health ◽  
Locally Advanced ◽  
Advanced Rectal Cancer ◽  
Locally Advanced Rectal Cancer

e15178 Background: The role of neoadjuvant FOLFOX in achieving clinical downstaging and improvement in quality of life (QOL) in patients with locally advanced rectal cancer (LARC) remains to be established. We are conducting a phase II prospective clinical trial to evaluate the use of six cycles of FOLFOX as neoadjuvant chemotherapy in patients with T2-T3/N0-N+ rectal cancer. We now report tumor clinical downstaging and patient-reported QOL in our first patient cohort. Methods: Eleven Patients enrolled in our phase II prospective trial. Patients received three months of FOLFOX (infusional fluorouracil, leucovorin, and oxaliplatin) administered every two weeks. After three weeks of recovery, each patient was treated with conventional chemo-radiotherapy (5FU or capecitabine) All patients had an MRI and endorectal ultrasound at baseline and after completion of FOLFOX. A compilation of validated QOL questionnaires were also administered before and after FOLFOX. Results: A total of 11 patients completed the chemotherapy regimen. Based on pelvic MRI, complete clinical response (T0N0) was achieved by seven patients (64%), one patient (9%) was clinically downstaged but three (27%) didn’t have any changes following FOLFOX. Importantly, we found no disease progression during the FOLFOX course. QOL assessment after FOLFOX regimen showed trend towards improvement in general health, mobility, bladder control and psychological health. These changes in QOL were not statistically significant due to the small sample size. Patients self-grading of their general health before starting FOLFOX was 50% compared to 75% after. Of the five patients with pain at time of diagnosis, four reported complete pain relief while the fifth reported improvement from extreme to moderate pain. Three patients reported improvement in their anxiety/depression. In terms of bowel function, although there was trend towards improvement in the urgency subscale, other bowel functions subscales were unchanged. In general, scores for mobility, selfcare, and bladder function were slightly better after FOLFOX. Conclusions: This study suggests that adding only six cycles of neoadjuvant FOLFOX before CRT not only resulted in clinical downstaging of (LARC) but showed a trend toward improved QOL. This result provides some reassurance for oncologists that this approach does not diminish QOL with no risk of disease progression during the time of neoadjuvant chemotherapy. These findings need to be validated in a larger phase III trial.

scholarly journals The Quality-of-Life Effects of Neoadjuvant Chemoradiation in Locally Advanced Rectal Cancer

2013 ◽  
Vol 85 (1) ◽  
pp. e15-e19 ◽  
Author(s):  
Joseph M. Herman ◽  
Amol K. Narang ◽  
Kent A. Griffith ◽  
Mark M. Zalupski ◽  
Jennifer B. Reese ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rectal Cancer ◽  
Locally Advanced ◽  
Advanced Rectal Cancer ◽  
Locally Advanced Rectal Cancer ◽  
Neoadjuvant Chemoradiation

Outcomes of Neoadjuvant Chemotherapy without Radiation for Rectal Cancer

2015 ◽  
Vol 32 (4) ◽  
pp. 275-283 ◽  
Author(s):  
Takuya Matsumoto ◽  
Suguru Hasegawa ◽  
Masazumi Zaima ◽  
Naoya Inoue ◽  
Yoshiharu Sakai
Keyword(s):  
Rectal Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Pathological Complete Response ◽  
Locally Advanced ◽  
Complete Response ◽  
Advanced Rectal Cancer ◽  
Locally Advanced Rectal Cancer ◽  
Short Term ◽  
Group 2 ◽  
Grade 3

Aim: The efficacy of neoadjuvant chemotherapy without radiation (NAC) in the treatment of rectal cancer remains unclear. This retrospective study was aimed at determining the pathological complete response rate and short-term outcomes of NAC in patients with locally advanced rectal cancer. Patients and Methods: We collected data on 159 consecutive patients treated for rectal cancer (cT3/cT4a, cN+, and cM0 status) at five tertiary referral hospitals between 2005 and 2010. Pathological complete response (pCR) and safety were assessed as the main outcomes in 124 eligible patients comprising 15 who received NAC (NAC group) and 109 who received no neoadjuvant chemotherapy (non-NAC group). Results: In the NAC group, 2 patients (13.3%) achieved a pCR (95% confidence interval: 1.7-40.5%) and 3 patients (20%) experienced grade 3/4 adverse events. No significant differences were found between the NAC and non-NAC groups in terms of short-term outcomes, including R0 proportion (100 vs. 96.3%, p = 0.45) and postoperative grade 3/4 complications (13.3 vs. 18.4%, p = 0.63). Conclusions: Neoadjuvant systemic chemotherapy without radiation appears to be safe, without worsening short-term outcomes, in patients with locally advanced rectal cancer. A further study is needed to verify these findings in larger samples.

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