Letter to the Editor: Dysphagia Score as a Predictor of Adverse Events Due to Triplet Chemotherapy and Oncological Outcomes in 434 Consecutive Patients with Esophageal Cancer

Abstract BackgroundAddition of docetaxel to cisplatin plus 5-fluorouracil (DCF regimen) for treatment of esophageal carcinoma can improve the clinical outcome, but it is associated with increased toxicity. The risk factors for severe toxicities associated with DCF treatment remain unknown.MethodsWe retrospectively reviewed the data of esophageal cancer patients who received DCF between July 2009 and April 2014 at the National Cancer Center Hospital. Docetaxel 70 mg/m2/day (day 1), cisplatin 70 mg/m2/day (day 1), and continuous infusion of 5-fluorouracil 750 mg/m2/day (days 1–5) were administered every 3 weeks. The risk factors for severe adverse events were explored.ResultsWe included 100 patients with a median age of 63 years (range: 37–76), among whom 81 were men, and 44 and 55 had performance status scores of 0 and 1, respectively. A total of 96 patients had squamous cell carcinoma, while 4 had adenocarcinoma. A total of 1, 12, 64, and 23 patients had clinical stages I, II, III, and IV, respectively. DCF was used as neoadjuvant therapy in 69 patients, induction before chemoradiotherapy in 23, and palliative in 8. Approximately 45 patients experienced grade 4 hematological adverse events, while 40 developed grade >3 non-hematological adverse events: anorexia, 12%; mucositis, 6%; and esophagitis, 2%. Multivariate analysis showed a significant association between dysphagia score >2 (P = 0.022) and febrile neutropenia, and between platelet count ≤27,500/µl and grade >3 mucositis and/or esophagitis (P = 0.007).ConclusionDuring DCF therapy, patients with dysphagia or decreased platelet count should be carefully managed.Trial registration: Not applicable

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Letter to the editor re: ‘serious adverse events and deaths in PCSK9 inhibitor trials reported on ClinicalTrials.gov: a systematic review’

Expert Review of Clinical Pharmacology ◽

10.1080/17512433.2021.1874346 ◽

2021 ◽

pp. 1-2 ◽

Cited By ~ 1

Author(s):

Marc S. Sabatine ◽

Robert P. Giugliano ◽

Gregory G. Schwartz,

Keyword(s):

Systematic Review ◽

Adverse Events ◽

Serious Adverse Events ◽

Pcsk9 Inhibitor ◽

Letter To The Editor

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OP270 Why The Haute Autorité de Santé Rejects the Widespread Use Of “Mini-Bypass”/One Anastomosis Gastric Bypass For Obesity In France

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462320000975 ◽

2020 ◽

Vol 36 (S1) ◽

pp. 4-4

Author(s):

Jean-Charles Lafarge ◽

Denis-Jean David ◽

Cédric Carbonneil

Keyword(s):

Esophageal Cancer ◽

Gastric Bypass ◽

Adverse Events ◽

Severe Obesity ◽

One Anastomosis Gastric Bypass ◽

Close Monitoring ◽

Efficacy And Safety ◽

Multicenter Rct ◽

Nutritional Complications

IntroductionOne anastomosis gastric bypass (OAGB) has become a widespread technique over the last few years in France, without any prior assessment and despite existing controversies among bariatric surgeons. An older bypass technique for treating obesity, the Roux-en-Y gastric bypass (RYGB), is available and reimbursed, having been assessed and approved for use in 2005. In 2019, the French Haute Autorité de Santé (HAS) assessed OAGB for the treatment of severe and massive obesity. This assessment, the first in the world, was undertaken for OAGBs carried out with a 200- or 150-centimeter biliopancreatic-limb (BP-limb) length.MethodsA systematic review (SR) of the literature and consultation of a working group consisting of both healthcare professionals (clinician and surgeons) and patients were carried out. The primary aim of our assessment was to determine whether the OAGB technique can replace RYGB. The efficacy and safety profile of OAGB was compared with RYGB in adult patients with massive, severe obesity. Complications and postoperative follow up specific to OAGB were identified.ResultsThe three selected randomized controlled trials (RCTs) could not confirm the superiority or the non-inferiority of OAGB, compared with RYGB, on the selected efficacy endpoints of weight loss, resolution of comorbidities, and quality of life. Adverse events reported for OAGB included severe nutritional complications and bile reflux that could potentially lead to lower esophageal cancer. In one RCT, the frequency of serious adverse events in the OAGB group was almost two times higher than in the RYGB group.ConclusionsHAS considered that OAGB carried out with a longer (200 centimeter) BP-limb is not a validated technique for the surgical treatment of massive, severe obesity. Thus, it cannot be considered an alternative to RYGB. There were insufficient data available on OAGB performed with a 150-centimeter BP-limb. Thus, HAS recommended undertaking a multicenter RCT to assess the efficacy and safety of OAGB. Patients who have already undergone OAGB should receive the same follow up as patients who have received RYGB, including close monitoring for nutritional complications and lower esophageal cancer and an endoscopic examination five years after surgery.

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Letter to the editor: combined CT texture analysis and nodal axial ratio for detection of nodal metastasis in esophageal cancer

British Journal of Radiology ◽

10.1259/bjr.20200352 ◽

2021 ◽

pp. 20200352

Author(s):

Jie Weng ◽

Jingwen Yang ◽

Zhe Xu ◽

Zhiyi Wang

Keyword(s):

Esophageal Cancer ◽

Texture Analysis ◽

Axial Ratio ◽

Nodal Metastasis ◽

Letter To The Editor ◽

Ct Texture Analysis

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PS02.125: NEOADJUVANT CHEMOTHERAPY PLUS SURGERY FOR NON-T4 CSTAGE II/III ESOPHAGEAL CANCER: A SINGLE INSTITUTION EXPERIENCE IN JAPAN

Diseases of the Esophagus ◽

10.1093/dote/doy089.ps02.125 ◽

2018 ◽

Vol 31 (Supplement_1) ◽

pp. 156-157

Author(s):

Masahiko Ikebe ◽

Mitsuhiko Ohta ◽

Masahiko Sugiyama ◽

Masaru Morita ◽

Yasushi Toh

Keyword(s):

Esophageal Cancer ◽

Postoperative Complications ◽

Neoadjuvant Chemotherapy ◽

Adverse Events ◽

Standard Treatment ◽

Conflicts Of Interest ◽

Radical Surgery ◽

Hospital Death ◽

Number Of Patients ◽

Grade 3

Abstract Background In Japan, following the results of JCOG 9907 trial, neoadjuvant chemotherapy (NAC) and radical surgery has been a standard treatment for Non-T4 cStage II/III esophageal cancer. Since 2009 we have also positioned NAC as standard treatment. We examined treatment outcomes and problems in our institute. Methods From 2009 to 2015, there were 64 patients with non-T4 stage II/III esophageal cancer treated with chemotherapy who are planned to undergo curative surgery. The standard NAC regimen consists of 2 courses of CDDP/5-FU (CF) therapy. As standard surgical procedure, subtotal esophagectomy, cervical anastomosis, three regional lymph node dissection were performed. Results The number of patients was 23/41 cases of cStage II/III respectively. 53 patients (88%) completed two courses of NAC. At the end of first course, NAC was terminated due to adverse events in 4 cases and due to the increasing tendency of tumors in 7 cases. NAC-induced adverse events of grade 3 or higher consists of myelosuppression in 27 cases (42%), appetite loss in 5 cases and so on. Surgery was performed in 61 cases (95%), of which R0 operation in 56 cases (88%), R1 operation in 3 cases and R2 operation in 2 cases. Three patients did not undergo surgery due to progressive disease. There were 7 cases (11%) of postoperative complications of Grade 3 or higher, but there was no in-hospital death. In the histological therapeutic effect, there were 5/41/7/4/3 cases for Grade 0/1a/1b/2/3, respectively. Three-year and five-year overall survival rate of all 64 patients were 68% and 47%. In 56 patients who underwent R0 surgery, they were 76% and 61% respectively. Conclusion From the viewpoint of adverse events and postoperative complications, NAC plus radical surgery for cStage II/III esophageal cancer could be performed safely. Considering that more than 60% of the patients belong to cStage III, this treatment strategy resulted in relatively favorable prognosis. Disclosure All authors have declared no conflicts of interest.

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Neoadjuvant cryotherapy improves dysphagia and may impact remission rates in advanced esophageal cancer

Endoscopy International Open ◽

10.1055/a-0957-2798 ◽

2019 ◽

Vol 07 (11) ◽

pp. E1522-E1527 ◽

Cited By ~ 1

Author(s):

Tilak Shah ◽

Vladimir Kushnir ◽

Pritesh Mutha ◽

Mankanchan Majhail ◽

Bhaumik Patel ◽

...

Keyword(s):

Esophageal Cancer ◽

Advanced Cancer ◽

Primary Outcome ◽

Outcome Measure ◽

Synergistic Effects ◽

Locally Advanced ◽

Secondary Outcome ◽

Secondary Outcome Measure ◽

Dysphagia Score ◽

Locally Advanced Cancer

Abstract Background and study aims Liquid nitrogen spray cryotherapy (LNSC) can provide rapid dysphagia relief, and is postulated to stimulate a local antitumor immune response. The aim of this prospective pilot clinical trial was to evaluate the safety and efficacy of LNSC when administered prior to chemoradiotherapy. Patients and methods Treatment-naïve adult patients with dysphagia at the time of biopsy-proven squamous carcinoma or adenocarcinoma of the esophagus were prospectively enrolled at two tertiary medical centers. Patients underwent a single session of LNSC. The primary outcome measure was change in dysphagia at 1 and 2 weeks post-cryotherapy. A secondary outcome measure was clinical complete response rate (CR) following chemoradiotherapy. Results Twenty-five patients were screened, of whom 21 patients were eligible and enrolled. There were seven with metastatic and 14 with locally advanced cancer. The primary outcome of dysphagia improvement of ≥ 1 point occurred in 15/21 patients (71 %) at 1 week, and 10/20 patients (50 %) at 2 weeks. The median dysphagia score improved by 1 at 1 week (P = 0.0003), and 0.5 at 2 weeks (P = 0.02). Six of nine patients (67 %) with locally advanced cancer who completed chemoradiation did not have residual tumor cells on mucosal biopsy, and five of nine patients (56 %) had a clinical CR. There were no serious cryotherapy-related complications. Conclusions LNSC provided safe and effective palliation for esophageal cancer patients who presented with dysphagia at index diagnosis. Its combination with chemoradiotherapy did not lead to any serious toxicity. Our study provides a scientific rationale for pursuing larger clinical trials addressing synergistic effects of combining LNSC with chemoradiation.

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