Abstract:Evaluation of the feasibility and efficacy of neoadjuvant concurrent chemoradiotherapy (CRT) with capecitabine and oxaliplatin in patients with locally advanced esophageal cancer. Forty-two patients were eligible for the study. The chemotherapy during CRT consisted of two cycles of intravenous oxaliplatin of 120 mg/m(2) on day 1 and oral capecitabine 825 mg/m(2) twice daily on days 1-14 at 3-week intervals. The radiotherapy (1.8 Gy/fraction/day to a total dose of 45 Gy) was delivered to the primary tumor site … Show more
“…In our series, toxicity was acceptable, with most adverse events being grade 1 or 2, and no treatmentrelated deaths being recorded. Dose reduction was required in 8 patients, and rates of grades 3 and 4 hematologic and nonhematologic toxicities were similar to those reported in other phase ii trials of preoperative crt (including oxaliplatin and 5fu-based chemotherapy) in esophageal or gej cancer [29][30][31][32] and also by our group in earlier work involving resected high-risk gastric cancer patients 13 . Those results are particularly interesting because our study used a higher radiotherapy dose than that reported in the German study (45 Gy vs. 30 Gy).…”
examination of surgical specimens demonstrated a 10% complete response rate. The median and mean survival times were 26 and 36 months respectively (95% confidence interval: 14 to 37 months and 30 to 41 months respectively). On multivariate analysis, TNM staging and clinical response were demonstrated to be the only independent variables related to long-term survival.
ConclusionsIn our experience, preoperative chemoradiotherapy with folfox4 is feasible in locally advanced gej adenocarcinoma, but shows mild efficacy, as suggested by the low rate of pathologic complete response.
“…In our series, toxicity was acceptable, with most adverse events being grade 1 or 2, and no treatmentrelated deaths being recorded. Dose reduction was required in 8 patients, and rates of grades 3 and 4 hematologic and nonhematologic toxicities were similar to those reported in other phase ii trials of preoperative crt (including oxaliplatin and 5fu-based chemotherapy) in esophageal or gej cancer [29][30][31][32] and also by our group in earlier work involving resected high-risk gastric cancer patients 13 . Those results are particularly interesting because our study used a higher radiotherapy dose than that reported in the German study (45 Gy vs. 30 Gy).…”
examination of surgical specimens demonstrated a 10% complete response rate. The median and mean survival times were 26 and 36 months respectively (95% confidence interval: 14 to 37 months and 30 to 41 months respectively). On multivariate analysis, TNM staging and clinical response were demonstrated to be the only independent variables related to long-term survival.
ConclusionsIn our experience, preoperative chemoradiotherapy with folfox4 is feasible in locally advanced gej adenocarcinoma, but shows mild efficacy, as suggested by the low rate of pathologic complete response.
“…Single arm phase I–II studies have demonstrated feasibility of oxaliplatin-based nCRT [9], [10], [11], [12], [13], [14], [15]. One randomised phase II study comparing oxaliplatin-5FU-based CRT with cisplatin 5FU-based CRT in patients with inoperable but localised oesophageal cancer has demonstrated no significant difference in survival or toxicity but the ease of administration of oxaliplatin over cisplatin makes it a more attractive option [16].…”
BackgroundOxaliplatin-capecitabine (OxCap) and carboplatin-paclitaxel (CarPac) based neo-adjuvant chemoradiotherapy (nCRT) have shown promising activity in localised, resectable oesophageal cancer.Patients and methodsA non-blinded, randomised (1:1 via a centralised computer system), ‘pick a winner’ phase II trial. Patients with resectable oesophageal adenocarcinoma ≥ cT3 and/or ≥ cN1 were randomised to OxCapRT (oxaliplatin 85 mg/m2 day 1, 15, 29; capecitabine 625 mg/m2 bd on days of radiotherapy) or CarPacRT (carboplatin AUC2; paclitaxel 50 mg/m2 day 1, 8, 15, 22, 29). Radiotherapy dose was 45 Gy/25 fractions/5 weeks. Both arms received induction OxCap chemotherapy (2 × 3 week cycles of oxaliplatin 130 mg/m2 day 1, capecitabine 625 mg/m2 bd days 1–21). Surgery was performed 6–8 weeks after nCRT. Primary end-point was pathological complete response (pCR). Secondary end-points included toxicity, surgical morbidity/mortality, resection rate and overall survival.StatisticsBased on pCR ≤ 15% not warranting future investigation, but pCR ≥ 35% would, 76 patients (38/arm) gave 90% power (one-sided alpha 10%), implying that arm(s) having ≥10 pCR out of first 38 patients could be considered for phase III trials. ClinicalTrials.gov: NCT01843829. Funder: Cancer Research UK (C44694/A14614).ResultsEighty five patients were randomised between October 2013 and February 2015 from 17 UK centres. Three of 85 (3.5%) died during induction chemotherapy. Seventy-seven patients (OxCapRT = 36; CarPacRT = 41) underwent surgery. The 30-d post-operative mortality was 2/77 (2.6%). Grade III/IV toxicity was comparable between arms, although neutropenia was higher in the CarPacRT arm (21.4% versus 2.6%, p = 0.01). Twelve of 41 (29.3%) (10 of first 38 patients) and 4/36 (11.1%) achieved pCR in the CarPacRT and OxcapRT arms, respectively. Corresponding R0 resection rates were 33/41 (80.5%) and 26/36 (72.2%), respectively.ConclusionBoth regimens were well tolerated. Only CarPacRT passed the predefined pCR criteria for further investigation.
“…[2][3][4] Although various chemotherapy regimens are available, esophageal cancer carries a very poor prognosis, with a mean survival time of less than 8.1 months. 5 Currently, neoadjuvant treatment (such as capecitabine and cisplatin with concurrent radiotherapy (RT) followed by esophagectomy) is considered the effective treatment for esophageal cancer, 6,7 leading to complete pathologic response at the time of surgical resection and improved local tumor control and eradication of micrometastases. 8 Clearly, the development of novel and potent therapeutics in/not in combination with RT to improve both local and distant tumor control in esophageal cancer is an urgent task.…”
External beam radiotherapy (EBRT) treats gross tumors and local microscopic diseases. Radionuclide therapy by radioisotopes can eradicate tumors systemically. Rhenium 188 (
188
Re)-liposome, a nanoparticle undergoing clinical trials, emits gamma rays for imaging validation and beta rays for therapy, with biodistribution profiles preferential to tumors. We designed a combinatory treatment and examined its effects on human esophageal cancer xenografts, a malignancy with potential treatment resistance and poor prognosis. Human esophageal cancer cell lines BE-3 (adenocarcinoma) and CE81T/VGH (squamous cell carcinoma) were implanted and compared. The radiochemical purity of
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Re-liposome exceeded 95%. Molecular imaging by NanoSPECT/CT showed that BE-3, but not CE81T/VGH, xenografts could uptake the
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Re-liposome. The combination of EBRT and
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Re-liposome inhibited tumor regrowth greater than each treatment alone, as the tumor growth inhibition rate was 30% with EBRT, 25% with
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Re-liposome, and 53% with the combination treatment at 21 days postinjection. Combinatory treatment had no additive adverse effects and significant biological toxicities on white blood cell counts, body weight, or liver and renal functions. EBRT significantly enhanced the excretion of
188
Re-liposome into feces and urine. In conclusion, the combination of EBRT with
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Re-liposome might be a potential treatment modality for esophageal cancer.
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