scholarly journals IMRT in carcinoma cervix: Maximizing the gain and nipping the side effects: RGCI experience

2016 ◽  
Keyword(s):  
Acute Toxicity ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Complete Response ◽  
Concurrent Chemotherapy ◽  
Radiation Dermatitis ◽  
Carcinoma Cervix ◽  
Definitive Radiotherapy ◽  
Entire Cohort

Objective: To present a single institutional experience with acute toxicity, patterns of failure and survival in carcinoma cervix treated using definitive radiotherapy with IMRT technique. Methods: It is a retrospective analysis of 64 patients with carcinoma cervix treated with definitive chemoradiation (IMRT) from April 2011 to Jan 2013. Patients with squamous or adenocarcinoma histology and no metastasis, treated with definitive radiotherapy (IMRT) with or without concurrent chemotherapy were included. Acute toxicities were presented as proportions and kaplainmeier computation was done to calculate 3 years disease free survival (DFS) and 3 years overall survival (OS). Results: Median follow up was months for the entire cohort. Mean age was 55.9 years (SD 9.93). Majority of patients (92.8%) had locally advanced disease (FIGO II and III) and squamous cell carcinoma (96.9%). Mean dose to pelvis with IMRT was 49.75 Gy (SD 1.78) followed by ICRT, EBRT boost and implant in 79.7%, 17.2% and 3.1% respectively (as indicated). Response evaluation done at 3 months of treatment completion showed 83.6% complete response, 11.5% partial response and 4.9% progressive disease. During follow up 21.6% developed recurrence - 44.4% failed locally, 16.7% at para-aortic nodal region and 38.9% at distant sites. The 3 year DFS and OS was 70.8% and 60.3% respectively. Patients had tolerable acute toxicities. Incidences of grade ≥3 acute toxicity were 3.1% for anemia, 10.9% for neutropenia, 25% for thrombocytopenia, 1.5% for nausea, 0% for vomiting, 12% for GU and 12% for GI toxicities. Incidence of grade I, II and III radiation dermatitis were 38.89%, 27.78% and 22.2% respectively. None developed grade IV radiation dermatitis. Conclusion: IMRT for carcinoma cervix seems to provide improved outcomes and toxicity profile, although it should be compared with conventional radiotherapy in a well randomized control setting so as to have true and meaningful comparison.

scholarly journals Role of interstitial brachytherpy using template (mupit) in locally advanced carcinoma cervix

2016 ◽  
Author(s):  
Ashish Bhange ◽  
Abhishek Gulia ◽  
Anirudh Punnakal ◽  
Anil Kumar Anand ◽  
Anil Kumar Bansal ◽  
...  
Keyword(s):  
Local Control ◽  
Residual Disease ◽  
Locally Advanced ◽  
Concurrent Chemotherapy ◽  
Interstitial Brachytherapy ◽  
Carcinoma Cervix ◽  
Advanced Carcinoma ◽  
Needle Position ◽  
Grade 3

Introduction: Locally advanced carcinoma cervix includes stages IIB, IIIA, IIIB and IVA. Interstitial brachytherapy has the potential to deliver adequate dose to lateral parametrium and to vagina. Hence, it is preferable in cases with distorted anatomy, extensive (lower) vaginal wall involvement, bulky residual disease post EBRT and parametrium involvement upto lateral pelvic wall. Aim and Objective: To determine clinical outcome and complications (acute and chronic) in locally advanced carcinoma cervix, treated with interstitial brachytherapy using template (MUPIT - Martinez universal perineal interstitial template). Materials and Methods: This study is a retrospective analysis of 37 cases of locally advanced carcinoma cervix (stage IIB-2, IIIB-30, IVA-5), treated with EBRT (dose-median 45Gy/25#) ± concurrent chemotherapy (CCT) - Inj. Cisplatin/Inj Carboplatin, followed by interstitial brachytherapy using MUPIT from December 2009 to June 2015. Initial treatment with EBRT ± CCT was followed by intertstitial brachytherapy. Under spinal anaesthesia and epidural analgesia, MUPIT application was done. Straight and divergent needles (median 26, range 19-29) were inserted to cover parametrium adequately. Needle position was verified with planning CT scan and Brachytherapy planning was done. Dose was normalized to 5 mm box surface from outermost needle with optimization of dose to OAR (Bladder, Rectum and Sigmoid colon). Prescription dose –25Gy in 5#. Treatment was delivered by Microselectron HDR using Ir192 source. Treatment fractions were delivered twice daily with min 6 Hrs. gap in-between fractions. Results: The median duration of follow-up was 25 months. Local control was achieved in 28 patients with residual disease in 7 patients and local recurrence in 2 patients. 10 patients had acute lower GI toxicity {Grade1 (n=6), Grade 2 (n=4)}, 2 patients had acute Grade 1 bladder toxicity. 1 patient had grade 3 and 1 patient had grade 4 chronic bladder toxicity. Chronic rectal toxicity was seen in 10 patients {Grade 2 (n=4), Grade 3 (n=4), Grade 4 (n=2)}. Conclusion: Local control was achieved in 28/37 patients (75.6%) and overall survival rate of 81.1% at median follow up of 25 months in patients with locally advanced carcinoma cervix and unfavorable prognostic factors.

PET-directed chemoradiation (CRT) with induction FOLFOX compared to induction carboplatin/paclitaxel (CP) in patients with locally advanced esophageal adenocarcinoma (EA).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4554-4554
Author(s):  
Rebecca Carr ◽  
Meier Hsu ◽  
Kay See Tan ◽  
Manjit S. Bains ◽  
Matthew Bott ◽  
...  
Keyword(s):  
Locally Advanced ◽  
Multivariable Analysis ◽  
Disease Free Survival ◽  
Complete Response ◽  
Rank Test ◽  
Complication Rates ◽  
Trimodality Therapy ◽  
Kaplan Meier ◽  
Multivariable Analyses

4554 Background: Induction chemotherapy with PET-directed CRT and surgery is the standard treatment for locally advanced EA at our institution. Following results of the CALGB 80803 trial, FOLFOX has recently replaced CP as the preferred induction regimen. Methods: We retrospectively evaluated patients with locally advanced EA treated with induction CP vs FOLFOX, followed by trimodality therapy between January 2010 and June 2019. Patients treated with CP with RT followed by surgery without induction chemo were also included. We compared pathological complete response (pCR) and near pCR (ypN0 with ≥90% response) rates in the induction FOLFOX group to the induction CP and no-induction groups. Univariable and multivariable analyses were used to adjust for confounding factors. Disease-free survival (DFS) was estimated by the Kaplan-Meier method and compared between groups using max-combo weighted log rank test. Results: 445 patients were included. Patients in the induction FOLFOX group had significantly higher pCR and near pCR rates vs induction CP patients. Notably, pCR rate was 38% among FOLFOX PET responders vs 19% in non-responders. In multivariable analysis, compared to induction CP, induction FOLFOX administration was an independent predictor of near pCR (OR: 2.22, 95%CI: 1.20-4.20, p = 0.012). Compared to 24% pCR rate among no-induction patients, induction FOLFOX pCR rate was slightly higher at 32%. DFS by 2-years was higher in induction FOLFOX compared to no-induction-treated patients (62% vs. 42%, p = 0.05). Postoperative complication rates were similar among the three groups. Conclusions: PET-directed CRT with FOLFOX instead of CP improves pCR and near pCR rates. Improved DFS was observed in the FOLFOX vs no-induction patients. Longer follow-up is needed to confirm any survival benefits. [Table: see text]

The 50-month results of the four non-platinum concurrent chemoradiation regimens for locally advanced cervical cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 5540-5540
Author(s):  
P. Kamnerdsupaphon ◽  
I. Chitapanarux ◽  
V. Sukthomya ◽  
V. Lorvidhaya
Keyword(s):  
Cervical Cancer ◽  
Locally Advanced ◽  
Survival Rates ◽  
Disease Free Survival ◽  
Complete Response ◽  
Advanced Cervical Cancer ◽  
Locally Advanced Cervical Cancer ◽  
Randomized Clinical Study ◽  
Disease Free

5540 Objectives: To determine the efficacy, disease free and overall survivals of radiation therapy in combination with four non-platinum chemotherapy regimens for locally advanced cervical cancer. Materials and Methods: Eligible patients were those with a diagnosis of locally advanced cervical cancer, under 70 years of age, and undergone the necessary prestudy investigations. All patients received external-beam pelvic irradiation to a minimum dose of 5,000 cGy, and brachytherapy delivered to bring the minimum total dose at point A to 7,500 cGy. Patients were randomized to receive one of four chemotherapy regimens: Arm1: oral 5FU 250 mg/m2/day, Arm2: mitomycin 12 mg/m2 on days 1 and 28 + oral 5FU 200 mg/m2/day, Arm3: mitomycin 12 mg/m2 on days 1 and 28 followed by 5FU 1,000 mg/m2/day on days 1 through 4 and 28 through 31, Arm4: oral hydroxyurea 25 mg/kg/day. Results: From September 1995 to October 2001, the study include 921 women; 226 in arm 1, 229 in arm 2, 234 in arm 3, and 232 in arm 4. The median follow-up time was 51.69 months. More than 89% of the patients achieved complete response. Disease free survival rates were 62.4% among arm 1, 63.8% among arm 2, 66.2% among arm 3, and 68.5% among arm 4. Overall survival rates were 77.4%, 79.5%, 80.8%, and 84.5% respectively. Conclusion: The efficacy of these regimens were not inferior to the standard platinum based regimen for locally advanced cervical cancer. This study demonstrates the results of large randomized clinical study of radiochemotherapy and requires the longer follow up time for the late complications. No significant financial relationships to disclose.

A phase II study of neoadjuvant therapy with cisplatin, docetaxel, panitumumab plus radiation therapy followed by surgery in patients with locally advanced adenocarcinoma of the distal esophagus (ACOSOG Z4051).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4062-4062 ◽  
Author(s):  
Carolyn E Reed ◽  
Paul A. Decker ◽  
Tracey E. Schefter ◽  
Bryan F Meyers ◽  
Mark K. Ferguson ◽  
...  
Keyword(s):  
Gastroesophageal Junction ◽  
Locally Advanced ◽  
Survival Rates ◽  
Pathologic Complete Response ◽  
Disease Free Survival ◽  
Complete Response ◽  
Concurrent Chemotherapy ◽  
Distal Esophagus ◽  
Tumor Control ◽  
Induction Phase

4062 Background: Multiple clinical trials have incorporated preoperative chemotherapy and radiation (RT) in an attempt to improve local tumor control, distant disease failure and overall survival rates for locally advanced but resectable adenocarcinoma of the distal esophagus and gastroesophageal junction (GEJ). This multicenter, cooperative group study combined active chemotherapy agents cisplatin (C), docetaxel (D) and the targeted EGFR agent panitumumab (P) in the induction phase followed by concurrent chemotherapy (CDP) and radiation. Pathologic complete response (pCR), a surrogate for improved survival, was the primary endpoint. Methods: From 01/15/09 to 07/22/11, 70 patients (pts) with Siewert I or II adenocarcinomas and clinical stages T3N0M0, T2-3N1M0 or T2-3N0-1M1a (celiac LN ≤ 2 cm) were accrued. Patients received cisplatin (40 mg/m2), docetaxel (40 mg/m2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, 9 with RT (5040 cGy, 180 cGy/day x 28d) beginning week 5. The decision rule had a 90% power with a 0.10 significance level to detect a pCR rate of at least 35%. Secondary objectives included near-pathologic complete response (near-pCR), toxicity, and overall and disease-free survival rates. Results: Five pts were ineligible. Of the remaining 65 pts (59 M, 6 F; median age 61), 12 pts did not undergo surgery (5 progressed, 4 refused, 3 other). Of the 58 evaluable pts, the pCR rate was 32.8% (90% CI: 22.6% -42.9%) and near-pCR 22.4% (90% CI: 13.4%-31.4%). Total doses of C, D, and P were achieved in 76%, 80%, and 73%, respectively (n = 70). 66 pts (94%) received the total RT dose. Sixteen pts (23%) had a grade 4+ non-heme adverse event possibly related to treatment. Venous thrombosis (5 pts) was most common. Conclusions: The CDP regimen in the neoadjuvant setting in patients with esophageal adenocarcinomas is active (pCR + near-pCR = 55.2%) and feasible. The toxicity though tolerable is substantial.

Induction treatment with FOLFOXIRI + bevacizumab (BV) followed by chemo-radiotherapy (CRT) + BV and surgery in locally advanced rectal carcinoma (LARC): The phase II TRUST trial.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 673-673
Author(s):  
Caterina Vivaldi ◽  
Aldo Sainato ◽  
Sara Lonardi ◽  
Piero Buccianti ◽  
Lorenzo Marcucci ◽  
...  
Keyword(s):  
Surgical Complication ◽  
Bowel Perforation ◽  
Anal Verge ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Disease Free Survival ◽  
Radical Resection ◽  
Complete Response ◽  
Induction Treatment

673 Background: Induction chemotherapy (CT) is a promising option in LARC. FOLFOXIRI + BV is an effective treatment in metastatic colorectal cancer. Methods: Patients (pts) with LARC at < 12 cm from the anal verge, N+ or cT4 or high risk cT3 (MRI criteria) underwent 6 cycles of FOLFOXIRI + BV followed by CRT (50.4 Gy + 5FU 225 mg/m2/day or capecitabine 800 mg/m2/bid 5 days/week + BV 5 mg/kg on days 1, 15, 28). Surgery was planned 8 weeks after CRT. Primary endpoint is 2-year disease-free survival (DFS). Results: From April 2012 to April 2015 48 pts were enrolled. At now, 46 pts completed induction CT, 43 completed CRT and 39 underwent surgery (5 pts ongoing). Pts characteristics were: median age, 53 years (range 30-74); cT2/cT3/cT4, 4%/60%/36%; cN0/N+, 4%/96%. Main grade (G) 3/4 toxicities during induction were neutropenia (42%), febrile neutropenia (4.2%), diarrhea (12.5. Two pts did not complete induction: one died due to bowel perforation and sepsis and one discontinued CT after acute kidney injury. Response rate (RR) after induction was 77%. Forty-five pts started CRT (1 pts underwent surgery after induction because of SAE). After the first 13 patients, protocol was amended and schedule of capecitabine modified due to an excessive rate of G3 toxicities during CRT: hand-foot syndrome (23%), proctalgia (23%), proctitis (23%) and diarrhea (15%). After amendment all pts completed CRT with acceptable toxicity: G3 proctitis 6.7% and proctalgia 3.3%. One pts died due to early progressive disease (PD) after CRT. RR after CRT was 88%. Surgery was low anterior resection 87%, abdomino-perineal resection 8%, other 5%. Radical resection was achieved in 95% of pts. Early post-surgical complication rate was 31%. Pathologic complete response was reached in 33% and pathological downstaging in 44% of pts. At a median follow up of 17 months, 8 pts had PD and estimated 2y-DFS is 72%. Conclusions: Induction CT with FOLFOXIRI + BV is feasible and highly active. A protocol amendment was needed due to toxicities during CRT. The rate of early post-surgical complications is not negligible. A longer follow up is needed for DFS. Clinical trial information: 2011-003340-45.

Does weekly versus daily low-dose of concurrent cisplatin have any effect on compliance and clinical outcomes in cases of locally advanced head and neck cancers?

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e17569-e17569
Author(s):  
Ayush Garg ◽  
Piyush Kumar ◽  
Arvind Kumar Chauhan ◽  
Pavan Kumar
Keyword(s):  
Statistical Difference ◽  
Low Dose ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Complete Response ◽  
Free Survival ◽  
Group I ◽  
Group Ii ◽  
Disease Free

e17569 Background: Concurrent Cisplatin with radiotherapy improves outcomes in locally advanced squamous cell carcinomas of the head neck.Cisplatin at 35mg/m2(weekly) raise compliance & hospitalization. There are only few reports on efficacy and toxicity of low dose Cisplatin (6mg/m2). Hence the purpose of this study was to evaluate the compliance and clinical outcomes between two concurrent cisplatin chemotherapy regimens & to see long term effects. Methods: Total 50 patients were included in study from Nov 2015 to Mar 2017 with 25 in each group. Radiotherapy given 70Gy/35# in 7weeks & Cisplatin at 35mg/m2 weekly (Group I) and 6mg/m2 daily (Group II). Assessment of toxicity was done by RTOG scoring criteria. WHO Response criterion was used to assess clinical response. Median follow up was 6 months. Results: Group I(80%) and Group II(84%)patients completed Radiotherapy. In Group I 48% patients received less than 6 cycles and Group II 40% received ≤25 cycles chemotherapy. Median OTT in Group I & II in was 51 & 52days. Neutropenia & Mucositis statistically insignificant between both groups.There was no statistical difference in complete response between the two groups. In Group I 40% patients developed Progressive disease on follow up as compared to 12% in Group II(p-0.02). After 1.5 years of follow up, Group I vs Group II 4 patients had complete response, 6 had recurrence & 11 vs 4 patients expired (p-0.03). At a median follow up of 6 months overall survival in Group I and II was 56% and 44%(p-0.39). While as median disease free survival in Group I & II was 6.6 & 11.9 months(p-0.14). Conclusions: Low dose daily Cisplatin offers ease of administration in the outpatient clinic, better tolerability and better quality of life.Group II patients were more compliant in terms of patients receiving chemotherapy or completing radiotherapy. At median follow up of 6 months there was no statistical difference in terms of overall and disease-free survival. The statistical difference was seen in terms of patients expired in Group I (44%) as compared to Group II (16%). Therefore, we need a larger number of patients for the use of low dose Cisplatin to be evaluated in future clinical trials.

Magnetic resonance imaging after external beam radiotherapy and concurrent chemotherapy for locally advanced cervical cancer helps to identify patients at risk of recurrence

2019 ◽  
Vol 29 (3) ◽  
pp. 480-486 ◽  
Author(s):  
Martina Aida Angeles ◽  
Pauline Baissas ◽  
Eric Leblanc ◽  
Amélie Lusque ◽  
Gwénaël Ferron ◽  
...  
Keyword(s):  
Tumor Size ◽  
External Beam Radiotherapy ◽  
Locally Advanced ◽  
Reduction Rate ◽  
Disease Free Survival ◽  
Concurrent Chemotherapy ◽  
Size Reduction ◽  
External Beam ◽  
Free Survival

ObjectiveTumor volume and regression after external beam radiotherapy have been shown to be accurate parameters to assess treatment response via magnetic resonance imaging (MRI). The aim of the study was to evaluate the prognostic value of tumor size reduction rate after external beam radiotherapy and chemotherapy prior to brachytherapy.MethodsPatients with locally advanced cervical cancer treated at two French comprehensive cancer centers between 1998 and 2010 were included. Treatment was pelvic external beam radiotherapy with platinum based chemotherapy followed by brachytherapy. Records were reviewed for demographic, clinical, imaging, treatment, and follow-up data. Anonymized linked data were used to ascertain the association between pre-external and post-external beam radiotherapy MRI results, and survival data.Results185 patients were included in the study. Median age at diagnosis was 45 years (range 26–72). 77 patients (41.6%) were International Federation of Gynecology and Obstetrics stage IB2-IIA disease and 108 patients (58.4%) were stage IIB-IVA. Median tumor size after external beam radiotherapy and chemotherapy was 2.0 cm (range 0.0–8.0) and median tumor size reduction rate was 62.4% (range 0.0–100.0%). Tumor size and tumor reduction rate at 45 Gy external beam radiotherapy MRI were significantly associated with local recurrence free survival (P<0.001), disease free survival, and overall survival (P<0.05). Tumor reduction rate ≥60% was significantly associated with a decreased risk of relapse and death (HR (95% CI) 0.21 (0.09 to 0.50), P=0.001 for local recurrence free survival; 0.48 (0.30 to 0.77) P=0.002 for disease free survival; and 0.51 (0.29 to 0.88), P=0.014 for overall survival).ConclusionsTumor size reduction rate >60% between pre-therapeutic and post-therapeutic 45 Gy external beam radiotherapy with concurrent chemotherapy was associated with improved survival. Future studies may help to identify patients who may ultimately benefit from completion surgery, adjuvant chemotherapy, and closer follow-up.

Pathologic complete response to standard preoperative chemoradiation in patients with locally advanced rectal cancer.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 686-686
Author(s):  
Madiha Naseem ◽  
Joshua Murray ◽  
Christine E. Simmons ◽  
Nancy Baxter ◽  
Marcus J. Burnstein ◽  
...  
Keyword(s):  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Disease Free Survival ◽  
Complete Response ◽  
Advanced Rectal Cancer ◽  
Locally Advanced Rectal Cancer ◽  
Response To Treatment ◽  
Significant Response ◽  
Free Survival

686 Background: Pathologic complete response (pCR) is associated with lower rates of recurrences and longer disease-free survival rates in locally advanced rectal cancer (LARC) patients. The purpose of this study was to evaluate clinical outcomes of neoadjuvant chemoradiation and pCR among these patients. Methods: A retrospective chart review was performed for all patients treated for LARC between August 2005 and May 2011 at St. Michael's Hospital, Toronto. Patients were stratified into pCR and no-pCR groups and compared with respect to tumor size, nodal status, and treatment characteristics. Descriptive statistics were calculated for all variables of interest. Chi-square and t-tests were conducted to test for associations between categorical and continuous variables respectively. Disease free survival was calculated as the time between diagnosis and recurrence date, censored at last follow up. Results: A total of 92 patient charts were reviewed; 21 patients had metastatic carcinoma and were excluded from analysis. 63.4% (45/71) were male, with a mean age of 61.2 years and median follow up of 15 months. 12.7% (9/71) of patients achieved a pCR, while the remaining 87.35% (62/71) were no-pCR. All pCR patients received and completed standard pre-operative chemotherapy-radiotherapy. 73.4% (52/71) of the patients had complications from chemoradiotherapy. Furthermore, there was a significant association between having a significant response to treatment and achieving a pCR; where 78% (7/9) of pCR patients had a significant response to treatment. Overall, 4/71 patients had a local recurrence, 22.2% (2/9) pCR and 3.2% (2/62) no-pCR. Those with no-pCR had a recurrence at 1 and 2.2 years post diagnosis, while those with pCR had a recurrence at 3.7 years. Conclusions: This study suggests that patients undergoing standard pre-operative chemoradiotherapy are likely to have a significant response and achieve a pCR. Based on this study, although a pCR does not prevent the risk of recurrence, it delays the onset of local recurrence. Longer follow-up is required to determine if these results are robust and to develop future studies to improve efficacy of treatment delivery in LARC patients.

Clinical results at 3 years of the ACCORD 12 randomized trial in rectal cancer.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 389-389 ◽  
Author(s):  
Jean-Pierre Gérard ◽  
David Azria ◽  
Sophie Gourgou-Bourgade ◽  
Thierry Conroy ◽  
Laurent Bedenne
Keyword(s):  
Rectal Adenocarcinoma ◽  
Disease Free Survival ◽  
Functional Results ◽  
Complete Response ◽  
Clinical Results ◽  
Concurrent Chemotherapy ◽  
Free Survival ◽  
Significant Difference ◽  
Intent To Treat

389 Background: The main end point of this trial was pathological response and published in 2010. We present the main clinical outcome after 3 years follow up. Methods: A total of 598 patients were included by 56 different French institutions between 2005 and 2008. Inclusion criteria were: resectable rectal adenocarcinoma accessible to digital examination and staged T3,4 Nx M0. Low anterior T2 were also eligible.Two neoadjuvant treatments were compared: CAP 45 (Radiotherapy 45 Gy/5 weeks with concurrent chemotherapy: capecitabine 1 600 mg/m2/day) versus CAPOX 50 (RT 50 Gy/5weeks with the same capecitabine plus oxaliplatin 50 mg/m2 /q week). Adjuvant chemotherapy was given to 253 patients and well balanced between both arms. All patients were analysed according to the intent to treat principle. Results: With a median follow up time of 36 months the main clinical results are presented in the table . There was no significant difference in local control, survival, toxicity and functional results. In an exploratory analysis, clinical complete response (24 pts) before surgery and pathological complete response (92 pts) were associated with an excellent disease free survival at 3 years respectively 92% and 90%. These results must be interpreted in reference with 3 other recent randomized trials involving the same patients: STAR 01 (Italy) NSABP R 04 (USA) (Table) CAO/ARO 04 (Germany). Conclusions: It is possible to conclude from this trial and the 3 other trials that: (1) oxaliplatin should not be included in the protocol (increased early toxicity and no effect on the pCR rate) (2) capecitabine is as efficient as fluorouracil (3) RT dose escalation to 50 Gy is improving pCR without increasing toxicity. A “CAP 50” regimen appears as safe and efficient in this neoadjuvant situation. [Table: see text]

scholarly journals Phase II randomized trial of capecitabine with bevacizumab and external beam radiation therapy as preoperative treatment for patients with resectable locally advanced rectal adenocarcinoma: long term results

BMC Cancer ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Ramón Salazar ◽  
◽  
Jaume Capdevila ◽  
Jose Luis Manzano ◽  
Carles Pericay ◽  
...  
Keyword(s):  
Overall Survival ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Complete Response ◽  
Relapse Free Survival ◽  
Free Survival ◽  
Link Type ◽  
Distant Relapse

Abstract Background Preoperative chemoradiotherapy with capecitabine is considered as a standard of care for locally advanced rectal cancer. The “Tratamiento de Tumores Digestivos” group (TTD) previously reported in a randomized Ph II study that the addition of Bevacizumab to capecitabine-RT conferred no differences in the pre-defined efficacy endpoint (pathological complete response). We present the follow-up results of progression-free survival, distant relapse-free survival, and overall survival data at 3 and 5 years. Methods Patients (pts) were randomized to receive 5 weeks of radiotherapy (45 Gy/25 fractions) with concurrent Capecitabine 825 mg/m2 twice daily, 5 days per week with (arm A) or without (arm b) bevacizumab (5 mg/kg once every 2 weeks). Results In our study, the addition of bevacizumab to capecitabine and radiotherapy in the neoadjuvant setting shows no differences in pathological complete response (15.9% vs 10.9%), distant relapse-free survival (81.0 vs 80.4 and 76.2% vs 78.2% at 3 and 5 years respectively), disease-free survival (75% vs 71.7 and 68.1% vs 69.57% at 3 and 5 years respectively) nor overall survival at 5-years of follow-up (81.8% vs 86.9%). Conclusions the addition of bevacizumab to capecitabine plus radiotherapy does not confer statistically significant advantages neither in distant relapse-free survival nor in disease-free survival nor in Overall Survival in the short or long term. Trial registration EudraCT number: 2009–010192-24. Clinicaltrials.gov number: NCT01043484.

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