scholarly journals The impact of pathological complete response after neoadjuvant chemoradiotherapy in locally advanced squamous cell carcinoma of esophagus

2018 ◽  
Vol 81 (1) ◽  
pp. 18-24 ◽  
Author(s):  
Jing-Wei Lin ◽  
Chung-Ping Hsu ◽  
Hui-Ling Yeh ◽  
Cheng-Yen Chuang ◽  
Chih-Hung Lin
2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 138-138
Author(s):  
A. Pisa ◽  
I. Moya ◽  
C. Pericay ◽  
E. Dotor ◽  
J. Alfaro ◽  
...  

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.


2013 ◽  
Vol 31 (11) ◽  
pp. 1415-1421 ◽  
Author(s):  
Renato G. Martins ◽  
Upendra Parvathaneni ◽  
Julie E. Bauman ◽  
Anand K. Sharma ◽  
Luis E. Raez ◽  
...  

Purpose The combination of cisplatin and radiotherapy is a standard treatment for patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). Cetuximab-radiotherapy is superior to radiotherapy alone in this population, validating epidermal growth factor receptor (EGFR) as a target. Erlotinib is a small-molecule inhibitor of EGFR. Adding EGFR inhibition to standard cisplatin-radiotherapy may improve efficacy. Patients and Methods Patients with locally advanced SCCHN were randomly assigned to receive cisplatin 100 mg/m2 on days 1, 22, and 43 combined with 70 Gy of radiotherapy (arm A) or the same chemoradiotherapy with erlotinib 150 mg per day, starting 1 week before radiotherapy and continued to its completion (arm B). The primary end point was complete response rate (CRR), evaluated by central review. The secondary end point was progression-free survival (PFS). Available tumors were tested for p16 and EGFR by fluorescent in situ hybridization. Results Between December 2006 and October 2011, 204 patients were randomly assigned. Arms were well balanced for all patient characteristics including p16, with the exception of more women on arm A. Patients on arm B had more rash, but treatment arms did not differ regarding rates of other grade 3 or 4 toxicities. Arm A had a CRR of 40% and arm B had a CRR of 52% (P = .08) when evaluated by central review. With a median follow-up time of 26 months and 54 progression events, there was no difference in PFS (hazard ratio, 0.9; P = .71). Conclusion Erlotinib did not increase the toxicity of cisplatin and radiotherapy in patients with locally advanced HNSCC but failed to significantly increase CRR or PFS.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e17513-e17513
Author(s):  
S. H. Manzoor Zaidi ◽  
Ahmed I. Masood ◽  
Syed Ijaz Hussain Shah ◽  
Irfan Hashemy

e17513 Background: This single arm, multicenter, phase 2 study was conducted to evaluate overall response (OR) rate and safety of subjects treated with induction regimen docetaxel + cisplatin, followed by chemoradiotherapy (CRT), in patients with locally advanced squamous cell carcinoma of oral cavity (stage III or IV) without distant metastasis. Methods: Induction regimen consisted of docetaxel 75mg/m2 and cisplatin 75mg/m2 on day 1; cycles were repeated every 21 days for 3 cycles with supportive G-CSF treatment beginning at first cycle. CRT consisted of weekly cisplatin 30mg/m2 for 4 weeks starting concomitantly with 60 Gy/30 fractions of conventional radiotherapy for 6 weeks. Primary and secondary efficacy criteria were OR rate at 3 weeks after cycle 3 and 8 weeks after last cycle of CRT respectively. Results: Three centers enrolled 35 patients. Primary efficacy endpoint: OR rate of evaluable patients (n = 27) was 88.9% (95% CI:71.9-96.2). Complete response (CR) was not achieved by any patients; partial response (PR) was achieved by 88.9% (24 of 27). From intent to treat (ITT) analysis OR rate was 68.6% (24 of 35). Secondary efficacy endpoint: OR rate of evaluable patients (n = 19) was 78.9% (95% CI:56.7-91.5) with CR and PR achieved by 2 (10.5%) and 13 (68.4%) patients respectively. Progressive disease (PD) was present in 4 patients. From ITT analysis CR rate was 5.7% (2 of 35) and OR rate was 42.9% (15 of 35). During induction most common hematological toxicity was leukopenia in 8 patients, with ≥Grade 3 leukopenia in 3 patients. Common non hematologic toxicities (all grades) were nausea, stomatitis and alopecia in 21, 18 and 18 patients respectively. During CRT most common adverse events were alopecia, stomatitis and nausea in 14, 13 and 13 patients respectively. Overall, leukopenia met seriousness criteria in 4 patients, and there was 1 case of febrile neutropenia. Overall, 7 patients died. Fatal events were not associated to investigational drugs. Conclusions: We observed an ITT response rate of 68.6% with docetaxel + cisplatin, suggestive of an active induction regimen with manageable safety profile. Clinical trial information: NCT02061631.


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