A phase II study of chemoselection with docetaxel, cisplatin, and 5–fluorouracil as a strategy for organ preservation in patients with resectable esophageal cancer (CROC trial).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4027-4027
Author(s):  
Chikatoshi Katada ◽  
Hiroki Hara ◽  
Hirofumi Fujii ◽  
Takako Eguchi Nakajima ◽  
Takayuki Ando ◽  
...  
Keyword(s):  
Organ Preservation ◽  
Clinical Stage ◽  
Progression Free Survival ◽  
Poor Response ◽  
Complete Response ◽  
Endoscopic Examination ◽  
Respiratory Dysfunction ◽  
Analysis Group ◽  
Resectable Esophageal ◽  
Resectable Esophageal Cancer

4027 Background: In patients with resectable esophageal squamous cell carcinoma (SCC), the outcomes of chemoradiotherapy (CRT) for good responders after three courses of induction chemotherapy (IC) with docetaxel, cisplatin, and 5–fluorouracil (DCF chemotherapy) were unclear. Methods: Patients with clinical stage IB–III (UICC 7th) resectable esophageal SCC were eligible. IC included docetaxel 75 mg/m2 on day 1, cisplatin 75 mg/m2 on day 1, and 5–fluorouracil 750 mg/m2 on days 1–5, repeated every 3 weeks for 3 cycles. The response was evaluated after 2 and 3 courses of IC. Patients were considered to have a “remarkable response (RR)” if an endoscopic examination with a central review showed shrinking of the primary lesion equivalent to T1 and the short axis of the metastatic lymph nodes were all < 1 cm on computed tomography—in other words, down staging to T1N0M0 stage IA. Patients were considered to have a “poor response (POR)” if they had progressive disease or no signs of reduction. Patients who did not achieve RR or POR were deemed to have “limited partial response (LPR)”. CRT was administered to patients who achieved RR, and surgery was performed in patients who achieved LPR or POR. CRT included cisplatin 75 mg/m2 on day 1 and 5–fluorouracil 1000 mg/m2 on days 1–4, repeated every 4 weeks for 2 cycles. Radiotherapy was administered as 50.4 Gy in 28 fractions. The primary endpoint was a 1–year progression free survival (PFS) for RR followed by CRT. Results: A total of 92 patients were enrolled. Two patients with non–SCC (n = 1) and distant metastasis (n = 1) were excluded. Therefore, 90 patients were included in the analysis group. Although 1 patient could not continue IC due to renal failure, the remaining 89 patients completed 3 courses of IC. The response after IC were RR in 58.4% (52/89), LPR in 41.6% (37/89), and POR in 0.0% (0/89). Three patients who achieved RR underwent surgery owing to renal dysfunction (n = 1), curative irradiation difficulty due to intestinal malrotation (n = 1), and CRT refusal (n = 1). Six patients who achieved LPR underwent CRT owing to surgery refusal (n = 3), unresectable tumors (n = 2), and respiratory dysfunction due to emphysema (n = 1). The complete response rate for RR followed by CRT was 89.8%. During the median follow–up period of 33 months (range: 1–85), the 1 and 3–years overall survival (OS) for the analysis group were 96.6% and 74.1%, respectively. The 1 and 3–years organ preservation survival for the analysis group were 56.8% and 45.3%, respectively. The 1 and 3–years OS for RR followed by CRT (n = 49) vs. LPR followed by surgery (n = 31) were 100% vs. 93.1% and 83.7% vs. 62.8%, respectively (p = 0.06). The 1 and 3–years PFS for RR followed by CRT were 89.8% and 70.0%, respectively. Conclusions: Three courses of DCF chemotherapy followed by CRT is an effective treatment for patients with resectable esophageal SCC who respond to the IC regimen. Clinical trial information: 8086.

Randomized phase II study of preoperative concurrent chemoradiotherapy with or without induction chemotherapy with S-1 and oxaliplatin in patients with resectable esophageal cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4093-4093
Author(s):  
Dok Hyun Yoon ◽  
Geundoo Jang ◽  
Jong Hoon Kim ◽  
Yong Hee Kim ◽  
Seyoung Son ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Induction Chemotherapy ◽  
Concurrent Chemoradiotherapy ◽  
Pathologic Complete Response ◽  
Dose Intensity ◽  
Progression Free Survival ◽  
Complete Response ◽  
Preoperative Chemoradiotherapy ◽  
Resectable Esophageal ◽  
Resectable Esophageal Cancer

4093 Background: The value of adding induction chemotherapy (ICT) to preoperative chemoradiotherapy followed by surgery has not been delineated well. Methods: Patients with stage II, III or IVA (by AJCC 6th ed.) esophageal cancer were randomly allocated to either 2 cycles of ICT (oxaliplatin 130 mg/m2 on day 1 and S-1 at 40 mg/m2 bid on days 1-14, every 3 weeks), followed by concurrent chemoradiotherapy (CCRT) (46 Gy, 2 Gy/day with oxaliplatin 130 mg/m2 on day 1 and 21 and S-1 30 mg/m2 bid, 5 days/week during radiotherapy) and surgery (arm A, n=48), or the same chemoradiotherapy followed by surgery without ICT (arm B, n=49). Primary outcome was to compare pathologic complete response (pCR). Results: Thirty six and 35 patients underwent surgery with or without ICT, respectively. pCR rate among those who underwent surgery was significantly lower in arm A (30.6% vs. 54.3%, p=0.043). However, no difference in progression-free survival (PFS) and overall survival (OS) was observed with a median follow-up of 19.5 mo (95% CI, 19.1-22.4). Two-year PFS rate was 63.8% in arm A and 55.2% in arm B (p=0.626) and 2-year OS rate was 70.1% and 62.6%, respectively (p=0.515). While 47 (arm A) and 48 (arm B) patients received at least 44 Gy of radiotherapy, relative dose intensity (RDI) for oxaliplatin during CCRT was significantly lower in arm A vs. arm B (92.7% ± 19.6% vs. 99.7 ± 1.8%, p=0.017). RDI for S1 did not significantly differ (94.1% ± 17.3% vs. 98.5% ± 5.9%, p=0.095). G3/4 thrombocytopenia was significantly common in arm A (37.5% vs. 4.1%, p <0.001), which contributed to lower RDI of oxaliplatin. Three patients in arm A, compared to none in arm B, failed to survive for 90 days after surgery. Conclusions: Adding this ICT to preoperative chemoradiotherapy seems to cause lower pCR rate and higher toxicity during CCRT.

NIMG-54. RADIOMIC FEATURES FROM LESION HABITAT PREDICT RESPONSE TO COMBINATION OF NIVOLUMAB AND BEVACIZUMAB IN PATIENTS WITH RECURRENT GLIOBLASTOMA: A FEASIBILITY STUDY

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi141-vi141
Author(s):  
Ruchika Verma ◽  
Yasmeen Rauf ◽  
Ipsa Yadav ◽  
Volodymyr Statsevych ◽  
Jonathan Chen ◽  
...  
Keyword(s):  
Progression Free Survival ◽  
Poor Response ◽  
Response Assessment ◽  
Complete Response ◽  
Recurrent Glioblastoma ◽  
Proportional Hazard ◽  
Free Survival ◽  
Cox Proportional Hazard ◽  
Expert Radiologist ◽  
Mri Scans

Abstract PURPOSE The use of immunotherapy in glioblastoma management is under active investigation. Glioblastomas are “cold” tumors, meaning that they have inactivated or fewer tumor infiltrative lymphocytes in addition to substantial tumor necrosis, attributing to their poor response to immunotherapy. A significant challenge is the apriori identification of Glioblastoma patients who will respond favorably to immunotherapy. In this work, we evaluated the ability of computerized MRI-based quantitative features (radiomics) extracted from the lesion habitat (including enhancing lesion, necrosis, and peritumoral hyperintensities) to predict response and progression-free survival (PFS) in recurrent GBM patients treated with combination of Nivolumab and Bevacizumab. METHODS Immunotherapy response assessment in neuro-oncology (iRANO) criteria along with PFS were used to analyze n=50 patients enrolled in a randomized clinical trial where patients received Nivolumab with either standard or low dose Bevacizumab. These patients were assessed to see if they had complete response, partial response, stable disease (i.e. responders, n=31), or disease progression (i.e. non-responders, n=19). Lesion habitat constituting necrotic core, enhancing tumor, and edema were delineated by expert radiologist on Gd-T1w, T2w and FLAIR MRI scans. COLIAGE radiomic features from each of the delineated regions were selected using minimum redundancy maximum relevance (mRMR) via cross-validation, to segregate non-responder patients from responders. A multivariable cox proportional hazard model was used to predict survival (PFS). RESULTS CoLlAGe correlation, sum average, and sum variance features (capture local heterogeneity) from the lesion habitat, were found to segregate non-responder patients from responders with an accuracy of 86%, followed by 80% using features from peritumoral hyperintensities and 78% from enhancing tumor. In our survival analysis, C-index of 0.688 was obtained using features from the entire lesion habitat, followed by peritumoral hyperintensities (0.675) and enhancing tumor (0.656). CONCLUSION Radiomic features from the lesion habitat may predict response to combination of Nivolumab and Bevacizumab in recurrent Glioblastomas.

Prospective study of biomarkers in squamous cell carcinoma of the anal canal (SCCAC) and their influence on treatment outcomes: Final results.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 3577-3577
Author(s):  
Camila Motta Venchiarutti Moniz ◽  
Rachel Pimenta Riechelmann ◽  
Suilane Coelho Ribeiro ◽  
Thomas Giollo Rivelli ◽  
Giovanni Mendonca Bariani ◽  
...  
Keyword(s):  
Clinical Stage ◽  
Predictive Biomarkers ◽  
Poor Response ◽  
Complete Response ◽  
Treatment Interruption ◽  
Pathogenic Mutation ◽  
Hiv Status ◽  
Primary Resistance ◽  
Ki 67 ◽  
Predictors Of Response

3577 Background: While chemoradiation (CRT) is a curative treatment for SCCAC, many patients (pts) present primary resistance. As a rare tumor, the predictors of response in this setting remain unknown. Methods: Prospective cohort study aimed to evaluate predictive biomarkers (Ki-67, PD-L1, Human papillomavirus (HPV), HIV status and mutations in tumoral DNA) associated with complete response (CR) following standard CRT for localized SCCAC. Eligible pts had T2-4/N0-3/M0 disease and were candidates to standard CRT. CR at 6 months (m) measured by RECIST 1.1 was the primary endpoint. DNA mutations were analyzed by next-generation (NGS) TruSight Tumor26 panel. HPV positivity was tested by PapilloCheck Test. KI-67 and PD-L1 were evaluated by immunohistochemistry. Results: 78 pts were recruited from Jan/2011 to Dec/2015. 75 were evaluable for response. Median age 57 years; 49 (65%) were stage III, and 9 (12%) were HIV+. At 6m 47 (62.7%) had CR, 18 (24%) partial response (PR) and 10 (13.3%) disease progression. HPV was evaluated in 67 and found in 47 (70.1%), the majority HPV16. PD-L1 was tested in 61, 10 (16.4%) had > 1% positive expression. Ki-67 was performed in 65, a median was 50% (1-90%) per patient. Clinical stage, HIV status, median KI-67, HPV and PD-L1 positivity, and treatment interruption were tested as predictive factors of CR in 6m by logistic regression. On multivariable analyses, ECII patients were 4.7 more likely to achieve CR than ECIII (OR 4.70 CI95%1.36-16.30; p = 0.015). HIV was borderline significant (OR 2.53 CI95% 0.9-7.1; p = 0.079). Analyzing the patients with PR and CR HIV+ was significantly associated with poor response. Patients HIV- were 5.7 more likely to achieve CR or PR (OR 5.72 CI95%2.5-13.0; p < 0.001). 25 patients had tumor samples proper for NGS, 17 had at least one pathogenic mutation. The most common mutated genes were PIK3CA and MET in 6. There was no differences in CR rates according to MET (50% vs 47.3%, p = 1) or PIK3CA (33.3% vs 47.3%, p = 0.6) mutation status. TP53 codon 72 polymorphism was present in 72% (n = 18) and was not associated with CR (44% VS 57%, p = 0.6). Conclusions: Our study suggests that HIV+ pts are less responsive to CRT.

Oxaliplatin (OXP) plus protracted infusion 5-fluorouracil (PIFU) and external beam radiation (EBRT) prior to surgery (S) for potentially curable esophageal adenocarcinoma (EA): A Southwest Oncology Group (SWOG) phase II trial with molecular correlates (S0356)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4513-4513
Author(s):  
L. Leichman ◽  
B. H. Goldman ◽  
J. K. Benedetti ◽  
K. G. Billingsley ◽  
C. R. Thomas ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
Combined Modality Therapy ◽  
Clinical Stage ◽  
Pathologic Complete Response ◽  
Progression Free Survival ◽  
Complete Response ◽  
The United States ◽  
External Beam Radiation ◽  
Beam Radiation

4513 Background: Although neoadjuvant combined modality therapy (NACMTX) has become a standard of care in the United States, median overall survival (OS) for patients (PTS) with EA has changed little over the past 25 years. Progression free survival (PFS) and OS after NACMTX depend on extent of primary tumor response. New regimens to increase pathologic complete response (pCR) are needed. Based on phase I data, SWOG designed a phase II trial (S0356) to test OXP with PI5FU and EBRT for PTS with EA. Objectives included pCR rate ≥ 25%, acceptable toxicity (TOX), PFS, OS and exploration of molecular parameters relevant to pCR. Methods: Eligibility: clinical stage II/III EA, ≥ 18 years, Zubrod PS ≤ 2, standard hematologic/non-hematologic values, and tumor < 2 cm into the gastric cardia. OXP 85 mg/m2 was given day (d) 1, 15 and 29; PI5FU 180 mg/m2/d was given d 8-d43. EBRT 180 cGy/d started d 8 x 25 fractions, 5 d/week to total dose 4500 cGy. S was planned 2–4 weeks after NACMTX, with a second cycle of OXP/ PI5FU after S. Central pathology review of surgical specimens was mandated. The trial used a 2-stage design; the trial was halted at 45 PTS to review pCR rate; it reopened to full accrual. Results: 98 PTS enrolled between 9/15/04 and 8/18/08. 6 PTS were ineligible; 2 PTS did not receive therapy (TX). 90 PTS, 84 men (93%), median age 61.7 years, were analyzed. 4 deaths (4.5%) were due to protocol TX; 2 due to NACMTX, 2 to S. 43% and 18% of PTS had grade 3/4 toxicity, respectively: 39% GI, 22% flu-like/fatigue, 17% pulmonary, 16% hematologic, 14% mucositis and 3% neurologic. 77 PTS (86%) underwent S. 30 PTS (33%) had pCR. 9 PTS (10%) had in-situ cancer or T1N0M0. <50% received postoperative CTX. Conclusions: OXP, PI5FU and EBRT for PTS with EA has produced the highest pCR rate reported to date for a cooperative group trial. Significant but manageable non-hematologic TOX was observed. S mortality is acceptable. Future trials built on this platform should plan to complete all TX before S. Tumor molecular profiles (analyses in progress) may predict benefit from this treatment. Data on PFS and OS will follow. [Table: see text]

Pathologic down-staging and complete pathologic response with gemcitabine and cisplatin neoadjuvant chemotherapy for muscle-invasive urothelial carcinoma of the bladder.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 307-307
Author(s):  
Sarah P. Psutka ◽  
Aria F. Olumi ◽  
Adam S. Feldman ◽  
Philip James Saylor ◽  
Donald S. Kaufman ◽  
...  
Keyword(s):  
Neoadjuvant Chemotherapy ◽  
Clinical Stage ◽  
Pathologic Complete Response ◽  
Progression Free Survival ◽  
Complete Response ◽  
Published Data ◽  
Free Survival ◽  
Carcinoma Of The Bladder ◽  
Muscle Invasive

307 Background: Neoadjuvant chemotherapy (NC) with MVAC (methotrexate, vinblastine, doxorubicin, and cisplatin) improves survival in muscle invasive urothelial cancer (MI−UC) with patients who achieve pathologic complete response (PCR) following radical cystectomy (RC). Gemcitabine/cisplatin (GC) NC is increasingly employed due to lower toxicity, however, its effectiveness as neoadjuvant therapy is controversial and multiple studies have reported poor utilization of this therapy, despite recent recommendations advocating for broader use. We describe pathologic and clinical outcomes following NC and RC. Methods: We retrospectively evaluated patients with MI−UC who received NC between 2003 and 2011 (n=38). Those who were treated with neoadjuvant radiation therapy (n= 15) were excluded. We compared initial clinical stage at surgery to final pathological stage and assessed overall−median progression free−survival. Mean follow−up was 25 months (SD 21.6, range 3 –76 months). Results: Twenty-three patients who received NC were included. Nineteen patients (82.6%) were treated with GC, 3 (13.0%) with MVAC, and 1 (4.3%) with gemcitabine/paclitaxel. The median time from start of NC to RC was 119 days (IQR 98.5−146). 10/19 (52.6%) patients treated with GC achieved PCR (pT0) from clinical stage T2 (n=5), cT3 (n=2) and cT4 (n=3), and 6 (31.2%) were downstaged to pT1 and pTIS from cT2. Two patients treated with MVAC were downstaged to pT1 and one achieved PCR. Median recurrence-free survival was 13 months (IQR 6−19 months) with 8 patients developing recurrent or metastatic UC following RC. At median follow-up of 19 months (IQR 8−31.2 months, Range 1−71 months), 15/23 (65.2%) patients were disease free, all of whom had received GC NC prior to cystectomy. Conclusions: Neoadjuvant GC for MI−UC was associated with a 52.6% PCR rate at RC and was well tolerated. These data compare favorably with published data on GC and MVAC as NC, and warrant further study.

Phase II study of chemoradiotherapy with docetaxel for elderly patients with stage II/III esophageal carcinoma: An updated report.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 208-208
Author(s):  
Akihiro Ohba ◽  
Jun Hashimoto ◽  
Ken Kato ◽  
Yoshinori Ito ◽  
Nobukazu Hokamura ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Esophageal Carcinoma ◽  
Clinical Stage ◽  
Performance Status ◽  
Complete Response ◽  
Stage Ii ◽  
Clinical Activity ◽  
Eligibility Criteria ◽  
Resectable Esophageal ◽  
Grade 3

208 Background: Definitive chemoradiotherapy (CRT) is one of the curative options for resectable esophageal carcinoma (EC). However, there are limited data on CRT in elderly patients, and it is difficult for elderly patients to receive chemotherapy containing cisplatin. The aim of this prospective study was to clarify the efficacy and safety of definitive CRT with docetaxel (DTX) in elderly patients. Methods: The eligibility criteria for this study were as follows: clinical stage II-III (UICC 6th, non-T4) EC; performance status (PS) 0-1; age > 70; and no desire for surgical treatment. Chemotherapy consisted of 6 cycles of a 1-h infusion of DTX (10 mg/m2) repeated weekly. Radiation was concurrently applied at a dose of 60 Gy in 30 fractions. We calculated that with a sample size of 37 patients, assuming that the expected and threshold 2-year survival was 50% and 30% with one-sided alpha of 5% with 80% power. Results: Between July 2008 and January 2011, 16 patients were enrolled. The study was closed prematurely due to poor accrual. The median age was 77 years (range, 73-81); male/female: 14/2; PS 0/1: 4/12; clinical Stage IIA/IIB/III: 3/4/9. Of the 16 patients, 14 (88%) completed the CRT, 1 patient (6%) could not complete the treatment because of grade 3 esophagitis, and 1 (6%) refused to continue the treatment. The median follow-up time was 57.9 months. Six patients achieved complete response (CR), resulting in a 37.5% CR rate (95% confidence interval (CI): 15.2-64.6). The 2-year overall survival rate was 62.5% (95% CI: 39.0-86.0). The median survival time was 27.8months (95% CI: 23.7-31.9). Acute toxicities included grade 3/4 esophagitis (31%), anorexia (13%), leukopenia (6%), neutropenia (6%), thrombocytopenia (6%), mucositis (6%), and infection (6%). No treatment-related deaths were observed. Grade 3 or 4 esophagitis, pleural effusion, pericardial effusion, and pneumonitis developed as late adverse events in 13%, 13%, 6%, and 6% of patients, respectively. Conclusions: Although it is difficult to conclude about efficacy of CRT with DTX for elderly stage II-III EC patients, considering that this study was terminated prematurely, CRT with DTX seemed to have substantial clinical activity. Clinical trial information: 000001846.

Efficacy and feasibility of neoadjuvant chemotherapy and chemoradiotherapy for elderly patients with stage IB/II/III (excluding T4) esophageal cancer: Retrospective study.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 135-135
Author(s):  
Takahiro Miyamoto ◽  
Takayuki Kii ◽  
Masahiro Gotoh ◽  
Ken Asaishi ◽  
Tetsuji Terazawa ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Survival Rate ◽  
Neoadjuvant Chemotherapy ◽  
Elderly Patients ◽  
Progression Free Survival ◽  
R0 Resection ◽  
Stage Ib ◽  
Resectable Esophageal ◽  
Resectable Esophageal Cancer ◽  
T4 Esophageal Cancer

135 Background: Neoadjuvant chemotherapy (NAC) of 5-fluorouracil plus cisplatin infusion (FP) is standard therapy for stage IB/II/III (excluding T4) esophageal cancer from results of JCOG9907 and definitive chemoradiotherapy (dCRT) of FP is one of the curative options for resectable esophageal cancer with organ preservation results of JCOG9906 in Japan. However, the efficacy and feasibility of NAC FP and CRT for elderly patients (pts) are unclear. Methods: We examined stage IB/II/III (excluding T4) esophageal cancer pts aged 70 or over, who received NAC FP or dCRT at our institution between April 2008 and August 2015, retrospectively. Results: 16 pts received NAC FP at least 1 course, while 5 pts received dCRT because of intolerability for surgery, reject of surgery, and patient's wish. Median age was 73/75 (NAC FP/dCRT) and pts in NAC FP had more advanced stage cancer compared with pts in dCRT (p = 0.02). With respect to the toxicity, bone marrow depression developed in dCRT with more high frequency compared with NAC FP, but no pts had febrile neutropenia. Adverse effects of fatigue, nausea and appetite loss developed in both group frequently. 3 pts were not performed surgery because of decreased respiratory function, decreased PS and progression disease and 4 pts did not achieved 4 cycle of FP infusion because of leukopenia, decreased renal function, and gastrointestinal toxicity. 12 pts in NAC FP undergone R0 resection surgery and 4 pts had a complete remission. The 5-year progression free survival rate was 50% (95% CI: 12-86%) in dCRT and 50% (95% CI: 20-80%) in NAC FP (p = 0.69). The 5-year overall survival rate was 50% (95% CI: 12-86%) in dCRT and 67% (95% CI: 36-88%) in NAC FP (p = 0.83). Conclusions: NAC FP and dCRT for stage IB/II/III (excluding T4) esophageal cancer might be effective even in pts ≥ 70 years of age. The therapy of dCRT might be one of options for elderly inoperative patients.

Intergroup phase III trial of neo-adjuvant chemotherapy, followed by chemoradiation and surgery with and without cetuximab in locally advanced esophageal carcinoma: First results from the SAKK 75/08 trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 4019-4019 ◽  
Author(s):  
Thomas Ruhstaller ◽  
Peter C. Thuss-Patience ◽  
Stefanie Hayoz ◽  
Sabina Schacher-Kaufmann ◽  
Jorge Riera-Knorrenschild ◽  
...  
Keyword(s):  
Esophageal Carcinoma ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Phase Iii ◽  
R0 Resection ◽  
First Results ◽  
Resectable Esophageal ◽  
Resectable Esophageal Cancer ◽  
Hospital Deaths ◽  
Neo Adjuvant Chemotherapy

4019 Background: We compared chemoradiotherapy followed by surgery with the addition of neoadjuvant and adjuvant cetuximab (cetux) in patients with esophageal carcinoma. Methods: Pts with resectable esophageal cancer (T2N1-3;T3-4aNx) received two cycles of induction chemotherapy (docetaxel 75mg/m2, cisplatin 75mg/m2) followed by chemoradiation (45 Gy, docetaxel 20mg/m2 and cisplatin 25mg/m2 weekly) and surgery or the same treatment with addition of neoadjuvant cetux 250mg/m2 weekly and adjuvant cetux 500mg/m2 bi-weekly for three months. Primary endpoint was progression-free survival (PFS). After a median follow-up of 4y 166 of the planned 180 events occurred (plateau reached). Results: 300 pts were treated between 2010-13: 88% male, median age 61y, 63% adenocarcinoma, 85% cT3/4a, 90% cN+. 84% completed neoadjuvant therapy, 87% were operated (cetux: 89%, control: 86%), 67% started and 50% completed adjuvant cetux-therapy. The R0 resection rate was 95% in the cetux-arm and 97% in the control-arm, there were 10 and 14 treatment-related deaths and 9 and 4 postoperative in-hospital deaths, respectively. Major differences in adverse events (grade >2) with addition of cetux were higher rate of allergic reactions and hypomagnesemia, but lower rate of dysphagia (-15%) and esophagitis (-4%) during chemoradiation. Conclusions: The addition of cetuximab to a multimodal therapy showed a statistically significant reduction of loco-regional recurrences which led to a statistically non-significant, but clinically relevant improvement of PFS and OS. Clinical trial information: NCT01107639. [Table: see text]

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