scholarly journals A prospective study on the role of neoadjuvant chemoradiotherapy on surgical outcome in resectable oesophageal carcinoma

2021 ◽  
Author(s):  
Hrishikesh Deka ◽  
Bhabesh Kumar Das ◽  
Rajiv Paul ◽  
Supriyo Majumdar
Keyword(s):  
Oesophageal Cancer ◽  
Clinical Stage ◽  
Locally Advanced ◽  
Neoadjuvant Chemoradiotherapy ◽  
Oesophageal Carcinoma ◽  
Tumor Burden ◽  
R0 Resection ◽  
Oesophagogastric Junction ◽  
A Prospective Study

Background: Initial results of the chemo-radiotherapy for oesophageal cancer followed by surgery study (CROSS) comparing neoadjuvant chemoradiotherapy (NACRT) plus surgery versus surgery alone in patients with squamous cell carcinoma and adenocarcinoma of the oesophagus or oesophagogastric junction showed a significant increase in 5-year overall survival in favour of the NACRT plus surgery group after a median of 45 months' follow-up. In this study we will interpret the short-term results of NACRT on resectable, locally advanced oesophageal carcinoma.Methods: Patients with clinically resectable, locally advanced cancer of the oesophagus or oesophagogastric junction (clinical stage T1N1M0 or T2-3N0-1M0, according to the AJCC, 8th  edition) were assigned to receive weekly administration of four cycles of NACRT (intravenous carboplatin [AUC 2 mg/mL per min] and intravenous paclitaxel [50 mg/m 2 of body-surface area] for 23 days) with concurrent radiotherapy (41·4 Gy, given in 23 fractions of 1·8 Gy on 5 days per week) followed by McKeown’s oesophagectomy from 01 January, 2020 to 31 May, 2021.Results: It was observed in our study that 38.46% patients had achieved a CPR after the administration of NACRT as per the CROSS-trial protocol which is comparable to PCR achieved in CROSS trial (29%). All the patients underwent an R0 resection during surgery (100%) which is comparable to CROSS trial (92%).12Conclusions: In our study which had collected data over a period of 17 months we learnt that the administration of NACRT in locally advanced oesophageal cancer was effective in reducing the tumor burden and achieving a satisfactory CPR of 38.46%.

272 10-YEAR FOLLOW-UP OF A RANDOMISED CONTROLLED TRIAL COMPARING NEOADJUVANT CHEMORADIOTHERAPY PLUS SURGERY VERSUS SURGERY ALONE FOR OESOPHAGEAL CANCER (CROSS)

2020 ◽  
Vol 33 (Supplement_1) ◽  
Author(s):  
B Eyck ◽  
J Lanschot ◽  
M Hulshof ◽  
B Wilk ◽  
J Shapiro ◽  
...  
Keyword(s):  
Overall Survival ◽  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Oesophageal Cancer ◽  
Squamous Cell ◽  
Locally Advanced ◽  
Neoadjuvant Chemoradiotherapy ◽  
Oesophagogastric Junction ◽  
Randomised Controlled

Abstract   Neoadjuvant chemoradiotherapy according to the Dutch randomised controlled ChemoRadiotherapy for Oesophageal cancer followed by Surgery Study (CROSS) has become standard of care for patients with cancer of the oesophagus or oesophagogastric junction. The aim of this study was to provide more insight into the ultra-long-term impact of CROSS neoadjuvant chemoradiotherapy on survival and disease recurrence for patients with oesophageal cancer. Methods Patients with locally advanced resectable squamous cell carcinoma or adenocarcinoma of the oesophagus or oesophagogastric junction were randomised between neoadjuvant chemoradiotherapy (five weekly cycles of intravenous carboplatin [AUC 2 mg/mL per min] and intravenous paclitaxel [50 mg/m2 of body-surface area]) with concurrent 41.4 Gy radiotherapy given in 23 fractions of 1.8 Gy, 5 days per week) plus surgery (nCRT arm) versus surgery alone (surgery arm). Primary endpoint was overall survival, defined from date of randomisation to date of all-cause death or to last day of follow-up. Secondary endpoints were cause-specific mortality and conditional survival. Analysis was by intention-to-treat. Results From 2004 through 2008, 178 patients were randomized to the nCRT arm and 188 to the surgery arm. Median follow-up for surviving patients was 146.6 months (IQR 133.5–157.2). Ten-year overall survival was 38% in the nCRT arm and 25% in the surgery arm (HR 0.68 [95%CI 0.53–0.87]). For patients with squamous cell carcinoma ten-year overall survival was 46% in the nCRT arm compared to 23% in the surgery arm. For patients with adenocarcinoma ten-year overall survival was 36% in the nCRT arm and 26% in the surgery arm. In the nCRT arm, ten-year oesophageal cancer-specific mortality was 47%. Conclusion Survival benefit of patients with locally advanced resectable squamous cell carcinoma or adenocarcinoma of the oesophagus or oesophagogastric junction receiving neoadjuvant chemoradiotherapy persists for at least 10 years compared to patients undergoing surgery alone.

Preoperative chemoradiotherapy with capecitabine and oxaliplatin in patients with locally advanced rectal cancer.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 548-548
Author(s):  
I. Marrodan ◽  
E. Azkona ◽  
S. Carrera ◽  
U. Aresti ◽  
B. Calvo ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Clinical Stage ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Neoadjuvant Chemoradiotherapy ◽  
Advanced Rectal Cancer ◽  
Locally Advanced Rectal Cancer ◽  
Sphincter Preservation ◽  
High Rate ◽  
R0 Resection

548 Background: Locally advanced rectal carcinoma is associated with high rate of abdomino-perineal amputation. We analyzed a cohort of patients (pts) diagnosed of locally advanced rectal cancer, treated with neoadjuvant chemoradiotherapy (QT-RT) with capecitabine and oxaliplatin (XELOX) followed by four cycles of adjuvant XELOX after surgery. Methods: Patients with locally advanced rectal cancer (T3-T4 and/or N+) were treated with oxaliplatin (50mg/m2 day 1, 8, 22 and 29) and capecitabine (1,650mg/m2 on days 1 to 14 and 22 to 35) combined with pelvic radiotherapy (180 cGy/day; 45Gy in 25 fractions). Surgery was scheduled 4 to 6 weeks after completion QT-RT. Four cycles of adjuvant XELOX were administered (capecitabine 2,000mg/m2 on days 1 to 14 and oxaliplatin 130mg/m2 on day 1) every 3 weeks. Main end points assessed were: rate of sphincter preservation, pathologic complete response (pCR) rate and the feasibility of postoperative chemotherapy. Results: From March 2007 to April 2010, 98 pts with locally advanced rectal cancer were included. M/F: 66/32; ECOG 0/1: 19/79; median age: 64 (38-81); upper/mid/distal rectum: 13/50/35; clinical stage: cT3/N- 9, cT2-T3/N+ 72, cT4/N- 4, cT4/N+ 13. Full dose of preoperative QT-RT was administered in 93 pts (95%). Main toxicities were grade 1/2 neurotoxicity (56/4) and grade 2/3 diarrhea (23/10). After treatment 96 pts underwent surgery. Sphincter preservation, R0 resections and pCR were achieved in 57, 93 pts and 17 (18%) patients, respectively, and 65 pts (66%) received all 4 cycles of adjuvant XELOX. Grade 3/4 toxicities included diarrhea 3/0, vomiting 2/0, neurotoxicity 5/0, hand-foot syndrome 1/0, neutropenia 4/0 and thrombopenia 0/4. 3-year progression-free and overall survival were 66% and 72%, respectively. No toxic deaths were reported. Downstaging in T/N stage was achieved in 53/71 pts (55/74%) respectively. Conclusions: Combination preoperative QT-RT with capecitabine and oxaliplatin is a well tolerated regimen and achieves encouraging rates of pCR, R0 resection, sphincter preservation and tumor downstaging in patients with locally advanced rectal cancer. No significant financial relationships to disclose.

681 PATTERN OF RECURRENCE IN PATIENTS WITH A PATHOLOGICALLY COMPLETE RESPONSE AFTER NEOADJUVANT CHEMORADIOTHERAPY AND SURGERY FOR OESOPHAGEAL CANCER

2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
Marloes Jongh ◽  
Ben M Eyck ◽  
Leonie R Werf ◽  
Eelke L A Toxopeus ◽  
J Jan B Lanschot ◽  
...  
Keyword(s):  
Overall Survival ◽  
Radiation Field ◽  
Oesophageal Cancer ◽  
Locally Advanced ◽  
Neoadjuvant Chemoradiotherapy ◽  
Complete Response ◽  
Distant Recurrence ◽  
Time To Recurrence ◽  
Phase Ii And Iii ◽  
Pattern Of Recurrence

Abstract   Neoadjuvant chemoradiotherapy (nCRT) and surgery is a widely used treatment for locally advanced resectable oesophageal cancer, with 20 and 50% of patients having a pathological complete response (pCR). Disease, however, still recurs in 20–30% of these patients. The aim of this study was to assess the pattern of recurrence in patients with pCR after nCRT and surgery. Methods All patients with pCR after neoadjuvant chemoradiotherapy and surgery included in the phase II and III ChemoRadiotherapy for Oesophageal followed by Surgery Study (CROSS) trials (April 2001—March 2009) and after the CROSS trials (September 2009—October 2017) were identified. The site of recurrence was compared to the applied radiation and surgical fields. Outcomes were median time to recurrence, overall and progression-free survivals. Results A total of 141 patients with a median follow-up of 100 (interquartile range [IQR] 64–134) months were included. Some 29 of 141 patients (21%) developed recurrence. Of these, four (14%) had isolated locoregional recurrence, 15 (52%) distant recurrence only and ten (34%) had both locoregional and distant recurrence. Among the 14 patients with locoregional recurrences, five were within the radiation field, seven outside the radiation field and two at the border. Median (IQR) time to recurrence was 24 (10–62) months. The 5-year overall survival was 74% and recurrence-free survival 70%. Conclusion Despite good overall survival, recurrence still occurred in 21% of patients. Most recurrences were distant, outside the radiation and surgical fields.

FRONTiER: A feasibility trial of nivolumab with neoadjuvant CF or DCF therapy for locally advanced esophageal carcinoma (JCOG1804E)—The short-term results of cohort A and B.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 202-202
Author(s):  
Shun Yamamoto ◽  
Ken Kato ◽  
Hiroyuki Daiko ◽  
Takashi Kojima ◽  
Hiroki Hara ◽  
...  
Keyword(s):  
Adverse Events ◽  
Checkpoint Inhibitors ◽  
Tnm Classification ◽  
Clinical Stage ◽  
Cell Cancer ◽  
Locally Advanced ◽  
Cytotoxic Agents ◽  
Feasibility Trial ◽  
R0 Resection ◽  
Breast Cancers

202 Background: The standard neoadjuvant chemotherapy (NAC) in Japan for locally advanced esophageal squamous cell cancer (ESCC) is CDDP + 5-FU (CF). Immune checkpoint inhibitors (ICI) such as nivolumab provide a survival benefit in ESCC, and have potential as NAC agents in lung, skin, and breast cancers, amongst others. However, whether ICI are efficacious in combination with cytotoxic agents, and whether ICI impact the safety of subsequent surgery after they are used as NAC for ESCC patients (pts) is currently unclear. Methods: FRONTiER is a multi-cohort phase I study designed to evaluate the safety and efficacy of ICI combined with NAC in ESCC. Histologically proven ESCC pts with cT1N1-3M0 or cT2-3N0-3M0 (8th-UICC TNM classification), 20–75 years old, PS ≤ 1, no prior therapies against any cancer were eligible. The primary endpoint was the incidence of dose-limiting toxicities (DLT) from the initial dose to the 30th postoperative day. This study contained 4 experimental cohorts, the NAC regimen of cohort A consisted of 2 courses of CDDP at 80 mg/m2, nivolumab at 360 mg/body on day 1 and 5-FU at 800 mg/m2 on days 1–5, q3wks. The regimen of cohort B consisted of one administration of nivolumab at 240 mg/body 2 weeks before chemotherapy, followed by the same treatments as cohort A. Results: Thirteen pts were enrolled to cohort A (n = 6) and B (n = 7). Characteristics were follows; median age: 62 (range: 34–75), PS 0/1: 9/4 pts, clinical stage I/II/III: 2/1/10 pts. One pt in cohort B was excluded from safety evaluation due to R2 resection, no DLTs were observed in 12 pts. The most frequent adverse events (≥ grade 3) were neutropenia in 6 pts during NAC, lung infection in 1, hyperglycemia in 1, pleural effusion in 1, infection (right neck) in 1, anemia in 1, abdominal pain in 1, and anatomic leakage in 1 during the postoperative period. Within 30 days post-operation, grade 2 adrenal insufficiency was observed in 1 pt of cohort B. No grade 4 adverse events or treatment-related deaths were seen. All pts received two courses of NAC + nivolumab and R0 resection was achieved in 12 pts (92.3%) without interruption of treatment. A pathological complete response was achieved in 2 pts (33.3%) in cohort A. Conclusions: Neoadjuvant CF + nivolumab with/without prior administration of nivolumab followed by surgery for locally advanced ESCC was well tolerated and showed promising efficacy. Clinical trial information: NCT03914443.

796 OUTCOMES OF DELAYED SURGERY IN PATIENTS WITH RESIDUAL DISEASE AFTER NEOADJUVANT CHEMORADIOTHERAPY FOR OESOPHAGEAL CANCER

2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
Hidde Overtoom ◽  
Ben Eyck ◽  
Berend Wilk ◽  
Bo Noordman ◽  
Pieter Sluis ◽  
...  
Keyword(s):  
Postoperative Complications ◽  
Oesophageal Cancer ◽  
Cox Regression ◽  
Residual Disease ◽  
Locally Advanced ◽  
Neoadjuvant Chemoradiotherapy ◽  
Progression Free Survival ◽  
Tumour Regression ◽  
Tumour Regression Grade ◽  
Negative Effect

Abstract   Standard treatment for locally advanced oesophageal cancer is neoadjuvant chemoradiotherapy (nCRT), plus surgery 6-8 weeks later. Time to surgery (TTS) after nCRT seems safe up to 12 weeks, and possibly improves patient condition and pathological response. However, it is unknown whether prolonged TTS is safe in patients with residual disease. The aim of this study was to investigate whether prolonged TTS leads to inferior surgical outcomes and survival in patients with residual disease after nCRT. Methods Patients with pathologically confirmed residual disease 4-6 weeks after nCRT who underwent preoperative PET/CT and surgery were selected from the preSANO-trial and SANO-trial. Patients were stratified by TTS ≤12 weeks versus TTS >12 weeks after completion of nCRT. Primary endpoint was overall survival (OS). Secondary endpoints were progression-free survival (PFS), peroperative unresectability, microscopically radical resections (R0), tumour regression grade (TRG), postoperative complications and risk of distant dissemination. Effects of TTS on OS, PFS and distant dissemination were analysed with Cox regression, adjusted for Charlson comorbidity index (CCI) at baseline, as well as WHO performance score and weight loss after nCRT. Results Forty-two patients were included in the TTS >12 weeks and 132 patients in the TTS ≤12 weeks group. Median follow-up was 20.6 months (IQR 16.1-30.3). Adjusted hazard ratios for OS and PFS were 0.50 (95% CI: 0.24-1.02) and 0.47 (95% CI: 0.25-0.91), respectively, in favour of TTS >12 weeks. Patients with TTS >12 weeks had more postoperative complications (89% vs 72%, p = 0.049), but comparable peroperatively unresectable tumours (11.9% vs. 3.8%, p = 0.11), R0-resections (89% vs 87%, p = 0.89), and TRG-scores (p = 0.97) compared to patients with TTS ≤12 weeks. Patients with TTS >12 weeks showed less distant dissemination (HR 0.40, 95% CI: 0.18-0.88). Conclusion Prolonged TTS beyond 12 weeks in patients with clinically proven residual disease after nCRT did not have a negative effect on OS and on PFS, but was correlated with an increase in postoperative complications. The (non-significantly) better survival outcomes for TTS >12 weeks may be explained by the fact that patients had a lower risk of developing distant dissemination, which may reflect improved selection prior to surgery.

Role of chemoradiotherapy alone in the management of unfit patients with nonmetastatic locally advanced squamous cell carcinoma of the esophagus.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 138-138
Author(s):  
A. Pisa ◽  
I. Moya ◽  
C. Pericay ◽  
E. Dotor ◽  
J. Alfaro ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Surgical Procedures ◽  
Squamous Cell ◽  
Locally Advanced ◽  
Neoadjuvant Chemoradiotherapy ◽  
Advanced Squamous Cell Carcinoma ◽  
Carcinoma Of The Esophagus

138 Background: Surgery is considered the best treatment for patients (pts) with non-metastatic locally advanced squamous cell carcinoma of the esophagus who have responded to neoadjuvant chemoradiotherapy (CRT) in terms of locoregional control. However, in these pts PFS and OS have not been proved superior to those achieved by CRT alone. Besides, the addition of surgery to CRT increases treatment-related morbidity and mortality. Unfit pts are usually declined for surgical procedures and included in definitive CRT programs. The aim of this study was to define the role of non-surgical strategies (CRT, CT or RT) in unfit pts considered non-optimal for surgical procedures. Methods: We retrospectively reviewed 90 pts with squamous cell carcinoma of the esophagus who had been diagnosed and treated at our institution from January 2004 to December 2009. Fifty-one pts were non-metastatic among which 19 underwent surgery and 32 a non-surgical procedure (CRT, CT, RT or BSC). Our aim was to identify OS, PFS, RR, data on comorbidity and toxicity in these 32 pts. Results: Thirty out of the 32 pts were men with a median age of 62 years (range 41-90). Comorbidity was detected in 17 pts (53%) as means of respiratory disorders (21.9%), cardiopathy (12.5%), hepatopathy (21.9%), synchronic tumors (25%) and metachronic tumors (25%). Seventeen pts received CRT, 7 received CT, 1 received RT and 7 received BSC alone (53%, 22%, 3% and 22% respectively). Grade 3 and 4 toxicities were observed in 15 pts (46.9%) as means of mucositis (18.8%), oesophagitis (15.6%), diarrhoea (12.5%) and neutropaenia (12.5%). One patient in the CRT group died of toxicity. RR was 43.8% (70.6% for CRT, 14.3% for CT alone). Median follow-up was 17.2 months. Median PFS was 11.3 ± 6.12 months (17.9 for CRT, 5.1 for CT alone). Median OS was 15.6 ± 7.6 months (6.9 for CT alone). Conclusions: Our experience with CRT alone in unfit pts with locally advanced squamous cell carcinoma of the oesophagus supports its use with a median PFS of 17.9 months and controllable toxicity. Data on median OS are lacking due to pending long-term follow-up. No significant financial relationships to disclose.

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