Cetuximab, paclitaxel, cisplatin and concurrent radiation in Chinese patients with locally advanced esophageal squamous cell carcinoma: An open-label, multicenter, phase II study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4073-4073
Author(s):  
Jinming Yu ◽  
Xue Meng ◽  
Jian hua Wang ◽  
Xindong Sun ◽  
Lv hua Wang ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Adverse Events ◽  
Cell Carcinoma ◽  
Phase Ii ◽  
Squamous Cell ◽  
Response Rate ◽  
Locally Advanced ◽  
Chinese Patients ◽  
Open Label ◽  
Grade 3

4073 Background: In China more than 90% of esophageal malignancies are of squamous cell carcinoma (SCC). We conducted this Chinese multicenter trial to determine the efficacy and safety of the addition of cetuximab with paclitaxel, cisplatin, and concurrent radiation for patients with esophageal SCC and to determine whether KRAS status predicts response. Methods: Patients with unresectable locally advanced cervical, upper or mid-esophageal SCC without distant metastasis were eligible for this open-label phase II trial. All patients received cetuximab (400 mg/m2 day 1 before chemoradiotherapy and 250 mg/m2 q1w × 7 weeks), paclitaxel (45 mg/m2 q1w × 7 weeks) and cisplatin (20 mg/m2 q1w × 7 weeks) with 59.4 Gy of radiation. The primary end point was response rate. Second end points included toxicity, overall survival (OS), progression-free survival (PFS), and KRAS mutation status. Results: Fifty-five patients were enrolled and evaluable to safety. Non-hematological adverse events were generally grade 1 or 2, and were most often rash (94.5%), mucositis (58.2%), fatigue (45.5%), nausea (41.8%) and hepatic dyfunction (40%). Hematologic adverse events included grade 3 neutropenia (32.7%) and grade 3 anemia (1.82%). Ten patients did not complete the protocol therapy (6 for chemotherapy dose delays, 1 for paciltaxel hypersensitivity, 1 by the treating physicians for unstated reasons, 1 for concurrent unrelated infection, and 1 for tracheo-esophageal fistula). The response rate was 97.7%. The 1-year OS and median OS was 87.3% and 16.8 months, the 1-year PFS and median PFS was 30.4% and 13.9 months, respectively. No mutations were detected at KRAS codons 12 or 13 in the 52 available specimens. Conclusions: Cetuximab can be safely administered with chemoradiation for Chinese patients with esophageal cancer and may improve the clinical response rate. KRAS mutations were too rare to be analyzed as a predictor of response.

scholarly journals Concurrent chemoradiotherapy with S-1 compared with concurrent chemoradiotherapy with docetaxel and cisplatin for locally advanced esophageal squamous cell carcinoma

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Xi-Lei Zhou ◽  
Chang-Hua Yu ◽  
Wan-Wei Wang ◽  
Fu-Zhi Ji ◽  
Yao-Zu Xiong ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Adverse Events ◽  
Esophageal Squamous Cell Carcinoma ◽  
Elderly Patients ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Concurrent Chemoradiotherapy ◽  
Response Rate ◽  
Locally Advanced ◽  
Grade 3

Abstract Background This retrospective study was to assess and compare the toxicity and efficacy of concurrent chemoradiotherapy (CCRT) with S-1 or docetaxel and cisplatin in patients with locally advanced esophageal squamous cell carcinoma (ESCC). Methods Patients with locally advanced ESCC who received CCRT with S-1 (70 mg/m2 twice daily on days 1–14, every 3 weeks for 2 cycles, S-1 group) or docetaxel (25 mg/m2) and cisplatin (25 mg/m2) on day 1 weekly (DP group) between 2014 and 2016 were retrospectively analyzed. Radiotherapy was delivered in 1.8–2.0 Gy per fraction to a total dose of 50–60 Gy. Treatment-related toxicities (Common Terminology Criteria for Adverse Events version 4.0), response rate, and survival outcomes were compared between groups. Results A total of 175 patients were included in this study (72 in the S-1 group and 103 in the DP group). Baseline characteristics were well balanced between the two groups. The incidence of grade 3–4 adverse events were significantly lower in the S-1 group than that of the DP group (22.2% vs. 45.6%, p = 0.002). In the DP group, elderly patients (> 60 years) had a significantly higher rate of grade 3–4 adverse events than younger patients (58.1% vs. 31.3%, p = 0.01). The objective overall response rate (complete response + partial response) was 68.1% in the S-1 group, and 73.8% the DP group (p = 0.497). The 3-year overall survival was 34.7% in the S-1 group, and 38.8% in the DP group (p = 0.422). The 3-year progression free survival in the DP group was higher than that in the S-1 group but without significant difference (33.0% vs. 25.0%, p = 0.275). Conclusion CCRT with S-1 is not inferior to CCRT with docetaxel and cisplatin and is better tolerated in in elderly patients with locally advanced ESCC.

Cetuximab combined with concurrent chemoradiotheray in Chinese patients with unresectable, locally advanced esophageal squamous cell carcinoma: A prospective, multicenter phase II trial.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15030-e15030
Author(s):  
Xue Meng ◽  
Jianhua Wang ◽  
Xindong Sun ◽  
Lvhua Wang ◽  
Ming Ye ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Adverse Events ◽  
Esophageal Squamous Cell Carcinoma ◽  
Phase Ii ◽  
Response Rate ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Chinese Patients ◽  
Multicenter Phase ◽  
Grade 3

e15030 Background: This multicenter phase II trial investigated cetuximab add to concurrent chemoradiotherapy for Chinese patients with esophageal squamous cell carcinoma (ESCC). Methods: Patients with unresectable locally advanced cervical, thoracic upper or mid-ESCC were eligible for this phase II trial. All patients received cetuximab (400 mg/m2 day 1 before chemoradiotherapy and 250 mg/m2 q1w × 7 weeks), paclitaxel (45 mg/m2 q1w × 7 weeks) and cisplatin (20 mg/m2 q1w × 7 weeks) with 59.4 Gy of radiation (1.8Gy/33f). The primary end point was response rate. Second end points included toxicity, overall survival (OS), progression-free survival (PFS), and KRAS mutation status. Results: Forty-five previously untreated patients (36 men, 9 women; median age, 59 year; performance status 0 or 1) with ESCC were treated and evaluated for clinical and radiographic response. After therapy, 29 patients (65%) achieved a complete response, and 15 (33%) patients achieved a partial response, the response rate was 97.7%. Non-hematological adverse events were generally grade 1 or 2, and were most often rash (94.5%), mucositis (58.2%), fatigue (45.5%), nausea (41.8%) and hepatic dyfunction (40%). Hematologic adverse events included grade 3 neutropenia (32.7%) and grade 3 anemia (1.82%). The 1-year PFS and OS rates were 87.3% and 91.1%, 2-year OS were 83.02%, respectively. No mutations were detected at KRAS codons 12 or 13 in all specimens. Conclusions: Cetuximab can be safely administered with chemoradiation for Chinese patients with esophageal cancer and may improve the clinical response rate. KRAS mutations were too rare to be analyzed as a predictor of response. Clinical trial information: NCT00815308.

Phase II study of gemcitabine concurrent with radiation in locally advanced squamous cell carcinoma of head and neck: Trial of the Cancer Research Group Pakistan

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 15520-15520 ◽  
Author(s):  
A. A. Javed ◽  
A. Shaharyar ◽  
I. H. Shah ◽  
M. A. Shah ◽  
T. N. Ansari ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Total Dose ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Squamous Cell ◽  
Overall Response Rate ◽  
Response Rate ◽  
Locally Advanced ◽  
Overall Response ◽  
Grade 3

15520 Background: The optimum radiosensitizing dose and schedule of gemcitabine for squamous cell carcinoma of head and neck are not known. The objectives of this study were to evaluate the efficacy and toxicity of weekly gemcitabine as a radiosensitizer concurrent with radical radiotherapy in locally advanced head and neck cancer. Method: Thirty-nine patients with stage III or IV B inoperable carcinoma of head and neck were enrolled. Eligible patients had histopathologically confirmed squamous cell carcinoma with age between 18–70 years. Patients had a KPS >70 with an adequate marrow, hepatic and renal function. No prior chemotherapy or radiotherapy was allowed. Patients with nasopharyngeal, glottic or sub-glottic cancer were excluded. Gemcitabine 150 mg/m2 or a total dose not exceeding 200 mg was given on day 1,8,15,22,29, and 36 during radiation treatment. Gemcitabine was infused in 200 ml of normal saline in 2 hours and radiation was delivered two hours after the completion of gemcitabine infusion. Conventional fractionation was used to deliver a total dose of 66 Gy. CTC version 2.0 of NCI and RTOG/EORTC Late Radiation Morbidity Scoring Scheme were used for evaluation of toxicity and RECIST was used for response evaluation. Results: Only 35 patients were considered evaluable for response. Complete response was seen in 8 (22.9%) (95% CI; 10.4–40.1%), partial response in 25 (71.4%), with an overall response rate of 94.3% (95% CI; 80.8–99.3%). All the thirty-nine patients were evaluable for toxicity. Grade 3 and 4 mucositis was seen in 28 (71.8%) and 2 (5.1%) patients respectively. Grade 3 pharyngeal toxicity was seen in 6 (15.4%). One patient developed pharyngo-cutaneous fistula. Despite vigorous symptomatic and supportive care acute toxicities led to treatment interruption in 16 (41%) of patients. Conclusion: Weekly gemcitabine at a dose of 150mg/m2 concurrent with radiation therapy gives a high overall response rate and a high rate of acute toxicity. No significant financial relationships to disclose.

A phase I/II study of divided-dose docetaxel, cisplatin, and fluorouracil (DCF) for patients with recurrent or metastatic squamous cell carcinoma of the esophagus.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 132-132
Author(s):  
Toshiyasu Ojima ◽  
Mikihito Nakamori ◽  
Masaki Nakamura ◽  
Makoto Iwahashi ◽  
Masahiro Katsuda ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Phase I ◽  
Cell Carcinoma ◽  
Phase Ii ◽  
Squamous Cell ◽  
Response Rate ◽  
Carcinoma Of The Esophagus ◽  
Metastatic Squamous Cell Carcinoma ◽  
Level 3 ◽  
Grade 3

132 Background: The aim of this phase I/II study was to evaluate the efficacy and safety of the combined use of docetaxel, cisplatin (CDDP) and 5-fluorouracil (5-FU) (DCF) in patients with recurrent/metastatic squamous cell carcinoma of the esophagus (SCCE). This study adopted divided doses of docetaxel and CDDP in order to reduce the toxicities of the treatment. Methods: The dose of docetaxel was escalated using the following protocol in the phase I stage: level 1, 30; level 2, 35 and level 3, 40 mg/m2, which was intravenously infused for two hours on days 1 and 8. CDDP was administered at a dose of 12 mg/m2 infused for four hours on days 1-5. The 5-FU was administered at a dose of 600 mg/m2continuously infused from day 1 to 5. This regimen was repeated every four weeks. Results: The study subjects were nine patients (phase I) and 48 patients (phase II). The recommended dose was determined as level 3 in phase I. In the phase II stage, the overall response rate was 62.5%, with a complete response rate of 12.5%. The median progression-free survival was six months, and the median overall survival was 13 months. Grade 3/4 toxicities of leukopenia, neutropenia and febrile neutropenia occurred in 64.6, 68.8 and 14.6% of the patients, while grade 3/4 non-hematological toxicities were relatively rare. No treatment-related death was recorded. Conclusions: This modified DCF regimen can be a tolerable definitive chemotherapy for unresectable SCCE because of its high efficacy, although adequate care for severe neutropenia is needed. Clinical trial information: NCT00915850.

scholarly journals Efficacy and safety of nimotuzumab in unresectable, recurrent, and/or metastatic squamous cell carcinoma of the head and neck: A hospital-based retrospective evidence

2018 ◽  
Vol 07 (03) ◽  
pp. 188-192 ◽  
Author(s):  
Sundaram Subramanian ◽  
Nithya Sridharan ◽  
V. Balasundaram ◽  
Sameer Chaudhari
Keyword(s):  
Squamous Cell Carcinoma ◽  
Adverse Events ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Squamous Cell ◽  
Standard Treatment ◽  
Response Rate ◽  
Locally Advanced ◽  
Efficacy And Safety ◽  
Metastatic Squamous Cell Carcinoma

Abstract Context: Role of nimotuzumab in locally advanced head and neck cancer (HNC) is well established in India; however, no clinical evidence is available for its role in recurrent and/or metastatic HNC. Aims: The aim of this study is to evaluate the efficacy and safety of nimotuzumab when added to standard treatment in unresectable, recurrent, and metastatic squamous cell carcinoma of the head and neck (SCCHN) Settings and Design: Hospital records of 14 patients diagnosed with recurrent and/or metastatic HNC with histologically confirmed squamous cell carcinoma and being treated with nimotuzumab along with standard treatments from December 2010 to December 2016 were retrospectively evaluated. Subjects and Methods: The tumor response rate and overall survival (OS) were analyzed. Toxicity and adverse events (AEs) were assessed as per common terminology criteria for adverse events (CTCAE) v 4. Results: Oral cavity was most commonly involved region followed by hypopharynx and oropharynx. At 24 weeks after completion of treatment, overall response rate (complete response (CR) + partial response (PR)) was 75%. Survival rate at 1, 2, and 3 years was 77.80%, 64.81%, and 64.81%, respectively. At a median follow-up of 15.17 months, median OS was not reached. All AEs were either Grade I (66.7%) or Grade II (33.3%). No Grade III or Grade IV AEs were observed. No added toxicity was observed due to nimotuzumab. Conclusions: In the first of its kind study, the addition of nimotuzumab to standard treatment showed promising response rate as well as survival outcomes in recurrent and/or metastatic SCCHN patients without producing additional toxicity.

Open label, non randomized, interventional study to evaluate response rate after induction therapy with docetaxel and cisplatin in unresectable locally advanced squamous cell carcinoma of head and neck (NCT02061631).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e17513-e17513
Author(s):  
S. H. Manzoor Zaidi ◽  
Ahmed I. Masood ◽  
Syed Ijaz Hussain Shah ◽  
Irfan Hashemy
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Response Rate ◽  
Locally Advanced ◽  
Complete Response ◽  
Hematological Toxicity ◽  
Advanced Squamous Cell Carcinoma ◽  
Open Label ◽  
Induction Regimen

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.

Phase III study of tri-modality combination therapy with induction docetaxel plus cisplatin and 5-fluorouracil versus definitive chemoradiotherapy for locally advanced unresectable squamous-cell carcinoma of the thoracic esophagus (JCOG1510: TRIANgLE)

2019 ◽  
Vol 49 (11) ◽  
pp. 1055-1060 ◽  
Author(s):  
Mitsumi Terada ◽  
Hiroki Hara ◽  
Hiroyuki Daiko ◽  
Junki Mizusawa ◽  
Tomohiro Kadota ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Adverse Events ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Response Rate ◽  
Locally Advanced ◽  
Phase Iii ◽  
Thoracic Esophagus ◽  
Current Standard ◽  
Definitive Chemoradiotherapy

Abstract A randomized phase III trial commenced in Japan in February 2018. Definitive chemoradiotherapy (CRT) with cisplatin plus 5-fluorouracil is the current standard treatment for locally advanced unresectable esophageal carcinoma. The purpose of this study is to confirm the superiority of induction chemotherapy with docetaxel plus cisplatin and 5-fluorouracil (DCF) followed by conversion surgery or definitive CRT over definitive CRT alone for overall survival (OS) in patients with locally advanced unresectable squamous-cell carcinoma of thoracic esophagus. A total of 230 patients will be accrued from 47 Japanese institutions over 4.5 years. The primary endpoint is OS, and the secondary endpoints are progression-free survival, complete response rate of CRT, response rate of DCF, adverse events of DCF and CRT, late adverse events and surgical complications. This trial has been registered at the Japan Registry of Clinical Trials as jRCTs031180181.

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