RA05.08: OPTIMAL RADIATION DOSE IN THE NEOADJUVANT TREATMENT OF ESOPHAGEAL CANCER: A COMPARATIVE EUROPEAN STUDY

2018 ◽  
Vol 31 (Supplement_1) ◽  
pp. 29-29
Author(s):  
Styliani Mantziari ◽  
Pierre Allemann ◽  
Michael Winiker ◽  
Marguerite Messier ◽  
Nicolas Demartines ◽  
...  

Abstract Background Current guidelines recommend the use of neoadjuvant chemo-radiation (NCR) for the treatment of locally advanced esophageal cancer, both types, adenocarcinoma (AC) and squamous cell carcinoma (SCC). So far, the optimal dose of radiotherapy to achieve a maximal tumor response within an acceptable toxicity is not yet determined. The aim of this study was to assess the impact of preoperative radiation dose on postoperative outcomes and long-term survival. Methods Consecutive patients operated in two European tertiary centers for AC or SCC, treated with NCR and surgery from 2000–2016 were assessed. Specific postoperative complications (i.e. anastomotic leakage, atrial fibrillation), histological tumor regression grade (TRG, Mandard score), overall and disease-free survival were compared among three patients groups: group A (41.4Gy), group B (45Gy), and group C (50.4Gy). The x2 or Fisher test were used for categorical variables and ANOVA for continuous variables. Survival analysis was done with the Kaplan-Meier method and log-rank test. Results There were 294 patients included; 41.5% (n = 122) had AC and 58.5% (n = 172) SCC. Overall, 9.2%/27 patients received 41Gy, 57.8%/170 patients 45Gy and 33%/97 patients received 50.4Gy. Carboplatin-Paclitaxel was the most frequently used chemotherapy for group A (62.9%), and 5FU-Cisplatin for groups B (69.4%) and C (51.5%). Postoperative anastomotic leakage was lower for group B (7.1%) compared to group A (22.2%) and C (13.4%) (P = 0.036), as was the occurrence of atrial fibrillation (11.8% group B, 33.3% group A and 19.6% group C, P = 0.013). Complete or excellent response (TRG 1–2) was significantly better for group B (58.2%), followed by group C (49.5%) and A (25.9%) patients (P = 0.012). Median overall survival was 48, 27 and 29 months for group A, B and C (P = 0.498), and median disease-free survival was 13, 27 and 18 months (P = 0.411), respectively. Conclusion Preoperative radiotherapy dose of 45Gy with 5FU-Cisplatin was associated with a better histological response and less postoperative adverse outcomes compared to 41Gy and 50.4Gy, with no significant differences in long-term recurrence and survival. The role of the type of chemotherapy and histological tumor type are important co-factors affecting outcome and must be further assessed. Disclosure All authors have declared no conflicts of interest.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16019-e16019
Author(s):  
Zhili Shan ◽  
Feng Guo ◽  
Hong Chen ◽  
Dapeng Li ◽  
Zhongqi Mao ◽  
...  

e16019 Background: Postoperative adjuvant chemotherapy is commonly given after the curative resection of gastric cancer (GC) in both Eastern and Western countries. Several studies have investigated the feasibility and safety of S-1 plus docetaxel or S-1 plus cisplatin. However, the best choice of adjuvant treatment for patients with gastric cancer is still debated. Apatinib, an oral small molecular of VEGFR-2 TKI, has been confirmed to improve OS and PFS with acceptable safety profile in patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy. In this study, we aimed to evaluate the efficacy and safety of apatinib combined with S-1/docetaxel for locally advanced gastric cancer (T3-4aN+M0). Methods: This is a prospective, randomized, controlled, multicenter clinical study. Patients with locally advanced gastric cancer, pathological stage T3-4aN+M0 who underwent D2 lymphadenectomy without prior anti-cancer therapy were included. All these patients were assigned to group A or B. Patients in group A received 6 cycles (21 days a cycle) of adjuvant therapy using S-1 (80-120mg/d, d1-14), and docetaxel (40mg/m2, d1). Group B received the same regimen with the addition of apatinib (250mg, qd.). The primary endpoint was disease-free survival (DFS). The final analysis cutoff date was 30 November, 2020. Results: A total of 45 patients were enrolled from January 2019 to November, 2010 and assigned to group A (21) or group B (24). The DFS was not reached in both of the groups. The 1-year disease-free survival rate was 60% in group A and 90% in the group B, while the difference was not significant. The main AEs in group A were anemia (55%), nausea (50%) and neutropenia (40%); The most common AEs in group B were anemia (45%) neutropenia (40%) and diarrhea (25%). There were no treatment-related deaths. The longest administered time of apatinib with no progression was 457 days. And the median time to receive apatinib was 329 days. Conclusions: Combination of apatinib with S-1/docexal chemotherapy shows clinical benefits in locally advanced gastric cancer (T3-4aN+M0), with tolerable toxicity. The study is still ongoing to reach our final endpoint, DFS. Clinical trial information: ChiCTR2000038900.


Vascular ◽  
2020 ◽  
pp. 170853812095011
Author(s):  
Ali Aycan Kavala ◽  
Yusuf Kuserli ◽  
Saygin Turkyilmaz

Objective To compare drug (paclitaxel)-coated balloon angioplasty with femoropopliteal bypass surgery in the treatment of femoropopliteal lesions. Methods A retrospective study was performed between January 2015 and January 2019, covering a four-year period. All subjects who underwent femoropopliteal bypass surgery and drug-coated balloon angioplasty over a four-year period were evaluated. The subjects’ demographic characteristics, lesion characteristics, treatment outcomes and disease-free survival were collected. Subjects were divided into the femoropopliteal bypass group (Group A) and the drug-coated balloon angioplasty (Group B) group. Results In total, 220 subjects were enrolled. Both Group A and Group B consisted of 110 subjects. The proportion of patients with a claudication distance between 0 and 50 m was significantly higher in Group A, and the proportion of patients with a claudication distance between 50 and 100 m was significantly higher in Group B ( p = 0.001). In terms of the Rutherford levels, moderate claudication was significantly higher in Group B, and severe claudication was significantly higher in Group A ( p = 0.001). The lesion length for the subjects in Group A was significantly longer than that in Group B (24.61 ± 2.79 mm for Group A and 18.59 ± 3.95 mm for Group B, p = 0.001). The stenosis degree in Group A was also significantly higher than that in Group B (96.82 ± 4.32% for Group A and 94.85 ± 4.55% for Group B, p = 0.001). The duration of the procedure, duration of hospitalization and rate of bleeding in Group A were significantly higher than those in Group B. The incidence of overall morbidity and reintervention rates in Group B were significantly higher than that in Group A. The preoperative ankle brachial index values of the subjects in Group B were statistically significantly higher than those in Group A (0.56 ± 0.08 for Group A and 0.61 ± 0.08 for Group B, p = 0.001). The change in the ankle brachial index measurement of the subjects in Group A with respect to the preprocedure value was significantly greater than that in Group B ( p = 0.001). For primary patency, there was a significant difference between the groups in the distribution of the duplex ultrasound results at the 3rd, 6th, 9th and 12th month control points ( p = 0.001). At all control points, Group A had better primary patency rates, whereas the secondary patency rates did not differ. In total, among the 220 patients, 125 (56.8%) were disease free, and 95 (43.2%) experienced recurrence. The mean disease-free survival times for Group A and Group B were 10.45 ± 0.28 months and 9.11 ± 0.37 months, respectively. The disease-free survival rates were significantly higher in Group A ( p = 0.001, p < 0.05). Conclusion Femoropopliteal bypass resulted in better disease-free survival rates than drug-coated balloon angioplasty and serves as an effective modality for the treatment of femoropopliteal lesions.


Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 4612-4612
Author(s):  
Mahasen Saleh ◽  
Ashraf Khairy ◽  
Mohammed Al-Mahr ◽  
Hassan El-Solh ◽  
AbdulRahman Al-Musa ◽  
...  

Abstract Acute myelocytic leukemia (AML) in Down Syndrome (DS) children is characterized by a young age of onset (< 2 years), a low white blood cell count and high frequency of Megakaryocytic leukemia. DS children with AML have higher disease free survival (DFS) rates as compared to non DS AML patients. Previous studies have suggested that intensification chemotherapy may not be necessary for the treatment of DS children with AML. The objective of this study was to clarify the effectiveness and toxicities of using high dose Cytosine Arabinoside (HD AraC) intensification in the treatment of DS AML. Clinical data for children (<14 years) with DS AML, diagnosed between September 2000 to May 2005, were retrieved from the hospital data base. Patients were divided into two groups; Group A patients received chemotherapy containing HD AraC, while Group B patients did not. A total of 15 patients were included, eight in Group A and seven in group B. The median age at diagnosis was 22 months (A=23 months, B=22 months). The two groups were matched regarding their clinical and laboratory parameters. There was no significant difference in DFS between groups A and B, 75% and 85% respectively (P = 0.82) at a mean observation period of 42.9 months for group A and 23.12 months for group B. The median time to relapse was 6 months for group A and 8 months for group B. The overall treatment related toxicity was higher in Group A patients but achieved only borderline significance (P = 0.06). However, when toxicity was assessed separately for induction and post induction phases of chemotherapy there were significantly more infectious events (17 v. 2; p=0.0006) in the post induction phase which includes HD AraC intensification in Group A. Even when only serious infections (bacteremia, fungal infection, sepsis) were included in the evaluation this difference persisted (7 v. 1; p=0.0339), with less toxicity for Group B patients. No such difference was noted between the two groups during induction chemotherapy. In conclusion the use of HD AraC in post-induction intensification phases for DS AML children does not improve DFS and is associated with more treatment related toxicity.


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6041-6041 ◽  
Author(s):  
B. Krishnamurthyreddy ◽  
M. S. Vidyasagar ◽  
R. Koteshwar ◽  
A. Shenoy ◽  
L. Viswanath ◽  
...  

6041 Background: Patients (pt) with advanced inoperable squamous cell carcinoma of the head and neck (SCCHN) have poor radiotherapy alone (RT) outcome. EGFR is over-expressed in >90% SCCHN. h-R3mAb (BIOMAb/nimotuzumab/TheraCIM) is a humanized monoclonal antibody, a validated oncotherapeutic-targeting EGFR. Objective: To investigate the safety and efficacy of concurrent h-R3mAb in combination with chemoradiotherapy of SCCHN. Methods: September 2004–2005, pt 18–70 yrs, SCCHN stageIII-IVA, 113 screened, 92 enrolled and randomly asssigned to, Group A: radical radiotherapy (pt) and Group B: chemoradiotherapy (pt). Randomization within Group A: [RT]v/s[RT+h-R3mAb] and within Group B: [RT+CT]v/s[RT+CT+ h-R3mAb] (n = 23 in each arm). Protocol: Radiotherapy: TD: 66 Gy,2Gy/Fr,5Fr/w,6.5wks. Radiation sensitizer (chemotherapy): CDDP-50mg/wk x 6wks. Study Drug (h-R3mAb): 200 mg/wk I.V.60min x 6weeks. Results: Evaluable (n = 76) in Group A-36 and Group B-40. F/u Analysis at 30 months after end of RT. Survival rate ITT: Group B: CT+RT+hR3- 69.5% v/s CT+RT-21.7% (p - 0.0011), Group A: RT alone - 21.7% v/s RT+ hR3–39.1% (ns). Progression-free survival: RT alone - 3(13.04 %) v/s RT+hR3mAb-8 (34.78 %), RT+CT-5 (21.74 %) v/s RT+CT+hR3mAb-13 (56.52%). Median overall survival (OS): CT+RT+hR3 - NR* v/s CT+RT- 21.96 months (hazard ratio [HR]-0.337, p - 0.0018) and RT alone - 25.02 v/s RT+hR3 - NR*(HR-0.678, p - 0.39). Disease-free survival: CT+RT+hR3- NR*v/sCT+RT-21.30 mths (HR-0.344, p - 0.0052) and RT alone-25.02 v/s RT+hR3- NA* (HR-0.599, p - 0.32). (NR*- median OS is yet to be reached). Safety: few grade - 1/2AE, no HAMA observed. OS per protocol - adding h-R3mAb to chemoradiation resulted in a reduction in risk of death (rrd) by 85% (HR 0.15, p - 0.0006) and to RT a 36 % rrd (HR0.64, p - 0.33). Conclusions: Concurrent use of h-R3mAb with RT or RT+CT is safe and efficacious. It enhances radiation and chemotherapy responses. Concurrent use of h-R3mAb with chemoradiotherapy enhances long-term loco-regional control and survival. Adding biological agents to physically targeted modality improves long-term therapeutic outcome of SCCHN. No significant financial relationships to disclose.


2007 ◽  
Vol 25 (24) ◽  
pp. 3719-3725 ◽  
Author(s):  
David P. Kelsen ◽  
Katryn A. Winter ◽  
Leonard L. Gunderson ◽  
Joanne Mortimer ◽  
Norman C. Estes ◽  
...  

Purpose We update Radiation Therapy Oncology Group trial 8911 (USA Intergroup 113), a comparison of chemotherapy plus surgery versus surgery alone for patients with localized esophageal cancer. The relationship between resection type and between tumor response and outcome were also analyzed. Patients and Methods The chemotherapy group received preoperative cisplatin plus fluorouracil. Outcome based on the type of resection (R0, R1, R2, or no resection) was evaluated. The main end point was overall survival. Disease-free survival, relapse pattern, the influence of postoperative treatment, and the relationship between response to preoperative chemotherapy and outcome were also evaluated. Results Two hundred sixteen patients received preoperative chemotherapy, 227 underwent immediate surgery. Fifty-nine percent of surgery only and 63% of chemotherapy plus surgery patients underwent R0 resections (P = .5137). Patients undergoing less than an R0 resection had an ominous prognosis; 32% of patients with R0 resections were alive and free of disease at 5 years, only 5% of patients undergoing an R1 resection survived for longer than 5 years. The median survival rates for patients with R1, R2, or no resections were not significantly different. While, as initially reported, there was no difference in overall survival for patients receiving perioperative chemotherapy compared with the surgery only group, patients with objective tumor regression after preoperative chemotherapy had improved survival. Conclusion For patients with localized esophageal cancer, whether or not preoperative chemotherapy is administered, only an R0 resection results in substantial long-term survival. Even microscopically positive margins are an ominous prognostic factor. After a R1 resection, postoperative chemoradiotherapy therapy offers the possibility of long-term disease-free survival to a small percentage of patients.


1986 ◽  
Vol 4 (12) ◽  
pp. 1765-1771 ◽  
Author(s):  
J Rouëssé ◽  
S Friedman ◽  
D Sarrazin ◽  
H Mouriesse ◽  
T Le Chevalier ◽  
...  

We report the largest series of induction chemotherapy for inflammatory breast carcinoma (IBC). Results of two chemotherapy protocols with radiation therapy (RT) (170 patients) are compared with results with radiation alone (60 patients) in the treatment of this disease. From 1973 to 1975, 60 patients (control, group C) received RT (45 Gy and 20 to 30 Gy boost) and hormonal manipulation. From 1976 to 1980, 91 patients (group A) were treated with induction chemotherapy: Adriamycin (Adria Laboratories, Columbus, Ohio), vincristine, and methotrexate (AVM) and RT on a cyclical schedule; and maintenance chemotherapy: vincristine, cyclophosphamide, and 5-fluorouracil (5-FU) (VCF). From 1980 to 1982, 79 patients (group B) received induction chemotherapy, Adriamycin, vincristine, cyclophosphamide, methotrexate, and 5-FU (AVCMF) and RT on a cyclical schedule and VCF maintenance. Hormonal manipulation was performed in all groups. Disease-free survival at 4 years was 15% for group C, 32% for group A, and 54% for group B (P less than .005 group C v group A, less than .00001 group C v group B, and less than .01 group A v group B). Total survival at 4 years was 42% for group C, 53% for group A, and 74% for group B (P = .17 group C v group A, less than .00001 group C v group B, and less than .001 group A v group B). Clinical assessment of tumor aggressiveness, nodal status, type of chemotherapy administered, and early response to chemotherapy (by third course) were all prognostic factors. There is an important, highly statistically significant benefit in terms of both disease-free survival and total survival observed in patients treated with the addition of chemotherapy compared with radiation alone in IBC.


2019 ◽  
Vol 32 (Supplement_2) ◽  
Author(s):  
Mantziari Styliani ◽  
St-Amour Penelope ◽  
Winiker Michael ◽  
Drmain Clarisse ◽  
Godat Sebastien ◽  
...  

Abstract Aim The aim of this study was to assess whether a preoperative HH≥3cm had an impact on histopathologic tumor response after neoadjuvant treatment, as well as on overall and disease-free survival. Background & Methods Hiatal hernia (HH) and long-term gastroesophageal reflux are known risk factors for esophageal cancer. Previous data suggest a negative impact of large hiatal hernias on survival after esophagectomy, as well as an increased toxicity after neoadjuvant treatment (1), although evidence remains scarce and the mechanism is not fully elucidated. All consecutive patients who underwent surgical esophagectomy for adenocarcinoma or squamous cell cancer of the esophagus and gastro-esophageal junction from 2012-2018 were assessed. Baseline oesogastroduodenoscopy reports and CT-scan images were retrospectively reviewed to identify the presence of a HH of ≥3cm (2). Response to neoadjuvant treatment as assessed by the Mandard score (3), postoperative outcomes and survival were compared between HH and non-HH patients (defined as HH<3cm or no HH at all). Categorical variables were compared with the x2 or Fisher’s test, whereas continuous ones with the Mann-Whitney-U test. The Kaplan-Meier method and log-rank test were used for survival analyses. Results Among the 174 included patients, 44 (25.3%) had a HH≥3cm upon diagnosis. HH patients compared to the non-HH had significantly more Barrett’s metaplasia (52.3% vs 20%, p<0.001), although no differences in baseline stage were observed. HH patients presented a worse response to neoadjuvant treatment compared to non-HH patients (TRG 4-5 in 40.5% vs 21.3%, p=0.033). Among HH patients, perioperative chemotherapy compared to radiochemotherapy showed a trend to higher complete response rates (TRG 1 in 25% vs 11.5%, p=0.059). In the radiochemotherapy subgroup (n=112), HH patients had worse complete response rates than non-HH patients (TRG 1 in 11.5% vs 26.7% respectively, p=0.050). However, no differences in overall or disease-free survival were observed between HH and non-HH patients in the whole cohort or in subgroup analyses. Conclusion A HH≥3cm is frequently encountered in esophageal cancer patients. The presence of HH was associated with worse response to neoadjuvant treatment, especially radiochemotherapy. However, the presence HH did not have an impact on long-term survival and recurrence.


2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 185-185
Author(s):  
Flavio Roberto Takeda ◽  
Ivan Cecconello ◽  
Ulysses Ribeiro ◽  
Rubens Antonio Aissar Sallum

185 Background: The surgical treatment of adenocarcinoma of the esophagogastric junction surgical treatment (AGEJ) is still controversial, particularly concerning to survival and postoperative complications. To compare thoracoscopic esophagectomy (group A) with transhiatal esophagectomy (group B) in patients with AGEJ in relation to the occurrence of complications and mortality; number of ressected lymph nodes, the positive and the ratio between the ressected and positive; overall and disease free survival; and survival after relapse. Methods: There was a selection of 147 patients from 2000 to 2017. Epidemiological data were analyzed and compared between the groups. Postoperative complications were evaluated. The anatomopathological staging was evaluated, analyzing the resected lymph nodes. Analysis of overall survival, disease free survival and survival after relapse were made, besides multivariate analysis of survival related factors. Results: In relation to the complications, group A presented greater occurrence of hoarseness and surgical infections. In relation to mortality, group A presented 2 cases (3.7%) and group B presented 4 (4.3%), without statistical difference. In group A, the average number of ressected lymph nodes was 31.88 and in group B was 20.73 (p < 0.001), however the average number of affected lymph nodes was 3.96 in group A and 4.25 in group B. The general overall survival was 42.3%, in group A was 38.9% and in group B was 47.6% (p = 0.298). In the multivariate analysis of overall survival only lymphatic invasion (p = 0.005), diabetes mellitus (p = 0.038) and surgical infection (p-0.001) were significant. However, in tumors with stage until 2B, group A overall survival was 80.4% and group B was 38.5% (p = 0.001). Conclusions: Both methods are safe with similar morbidity and mortality rates. Transthoracic thoracoscopic esophagectomy allows a larger ressection in the number of lymph nodes. Overall survival and disease free survival are similar, however until stage 2B thoracoscopic esophagectomy improves overall survival. Diabetes and lymphatic invasion interfere in overall and disease free survival.


2016 ◽  
Author(s):  
S. Singh ◽  
V. Goel ◽  
V. Talwar ◽  
S. Raina ◽  
S. Mitra ◽  
...  

Background: Cervical cancer is ranked as the most common cancer in Indian women, second most common cancer worldwide and the leading cause of death in the developing countries. In the developing countries majority of the patients are diagnosed at locally advanced stages. The standard treatment of locally advanced cervical cancer is concomitant chemoradiation (CTRT) using platinum based chemotherapy. However, some randomized studies have shown improved results for patients receiving neoadjuvant chemotherapy (NACT) followed by surgical resection in comparison to patient receiving radiation alone. The present study was designed to compare response to the treatment and survival of and NACT followed by radical surgery (RS) with CTRT in the patients of uterine cervix of a tertiary cancer care centre. Patients and Methods: Retrospective study was performed in locally advanced/advance stage patients of cervix UTERI registered in the institute between years 2009 to 2013. Patients were included in the two groups, group A consists of 89 patients who have received NACT + RS and 67 patients in group B who have received CTRT. Clinical records were reviewed with particular reference to presenting complaint, clinical stage, response to the therapy, disease free survival and overall survival. Statistical analysis was done using SPSS version 22. Results: In the neoadjuvant group (group A) (n=89) the median age of patients was 53 years (range 31-80 years), most of the patients (70%) were presented with complaint of postmenopausal bleeding. Of the total patients, 69 (77.5%) underwent to radical surgery and 5 (8.5%) received radiotherapy after NACT. From 69 patients, who had undergone to surgery, 54 (78.3%) had also received radiation. The overall response to induction chemotherapy was 84%. In the chemo radiation group (group B) (n=65) median age was 56 years (33-75 years). Vaginal bleeding (34%) followed by postmenopausal bleeding (32%) was major presenting complaint in this group. Overall response to the complete treatment was 91%. The median follow up time was 14.3 months in group A and 12.2 months in group B. The disease free survival for NACT group was 32 months (95% CI 26.8-36.5) whereas for CTRT group it was 28 months (95% CI 23.5-33) with 12 and 13 recurrences per group (p = .226). In NACT group overall survival was 46.2 months (95% CI 44-48.3) and for CTRT group it was 38.3 months (95%CI 36.6-40) with 3 and 2 deaths per group (p=.883). Conclusion: Present study shows comparable results, with no difference in survival between both the groups. However, NACT + RS group had showed better disease free and overall survival than another group. Further studies should be performed with larger number of patients and longer duration of follow up.


2017 ◽  
Vol 25 (1) ◽  
pp. 12-14
Author(s):  
Akimori Toyokazu ◽  
Hiromichi Maeda ◽  
Norihito Kamioka ◽  
Toshichika Kanagawa ◽  
Susumu Tsuda ◽  
...  

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