scholarly journals Phase IIb trial comparing two concurrent cisplatin schedules in locally advanced head and neck cancer

2017 ◽  
Vol 06 (02) ◽  
pp. 064-068
Author(s):  
Lekha Madhavan Nair ◽  
R. Rejnish Kumar ◽  
Kainickal Cessal Thomachan ◽  
Malu Rafi ◽  
Preethi Sara George ◽  
...  

Abstract Background: Concurrent chemoradiation with 3 weekly cisplatin (100 mg/m2) is the standard of care for locally advanced head and neck cancer. However, this regimen has been shown to be associated with lesser compliance and higher toxicities. Hence, there is a need to explore alternative concurrent cisplatin regimens. Objectives: The objective of this study was to compare the efficacy and toxicities of 3 weekly cisplatin (100 mg/m2) with weekly cisplatin (40 mg/m2) concurrently with radiation in patients with locally advanced head and neck cancer. Patients and Methods: This phase IIb trial randomized 56 patients with Stage III and IV squamous cell carcinoma of oropharynx, hypopharynx, and larynx to Arm A or Arm B. Arm A received cisplatin 100 mg/m2 3 weekly and Arm B received cisplatin 40 mg/m2 weekly concurrently with radiation. The primary end point was disease-free survival (DFS) and secondary end points were overall survival (OS) and acute toxicity. DFS and OS were estimated using Kaplan–Meier method, and log-rank test was used to assess the difference in these distributions with respect to treatment. Results: The 2-year DFS in Arm A and Arm B was 64.5% and 52.8%, respectively (P = 0.67). The OS at 2 years was 71% and 61.1% in Arm A and Arm B, respectively (P = 0.61). There were no significant differences in acute hematological, renal, or mucosal toxicities between the two arms. Conclusion: This study showed a nonsignificant improvement in DFS and OS in the 3 weekly cisplatin arm over the weekly arm with comparable toxicities. The trial is registered with Clinical Trial Registry of India (CTRI registration number: CTRI/2013/05/003703, URL-http://ctri.nic.in).

2018 ◽  
Vol 18 (1) ◽  
pp. 21-25 ◽  
Author(s):  
Sandeep Muzumder ◽  
Nirmala Srikantia ◽  
Ganesha Dev Vashishta ◽  
Avinash H. Udayashankar ◽  
John Michael Raj ◽  
...  

AbstractAimWeekly low-dose cisplatin is routinely used in concurrent chemoradiation (CCRT) in locally advanced head and neck cancer (LAHNC), despite 3-weekly cisplatin being the standard of care. We compared compliance, toxicity and efficacy in weekly versus 3-weekly cisplatin CCRT in LAHNC.Materials and methodsIn this retrospective study, weekly cisplatin 50 mg flat dose was compared with 3-weekly cisplatin 100 mg/m2, when given in CCRT in LAHNC with curative intent. The study outcome was compliance, toxicity, loco-regional control (LRC), disease-free survival (DFS) and overall survival (OS).ResultsEighty-four patients received CCRT from January 2013 to June 2017, 40 in weekly and 44 in 3-weekly arm. There was no difference between the arms not completing scheduled radiation therapy or chemotherapy. Patient receiving 200 mg/m2 cisplatin is higher in 3-weekly arm compared with weekly arm (75 versus 40·9%; p<0·0015). Compared with 3-weekly arm, more patient in weekly arm developed grade ≥3 mucositis (52·5 versus 15·9%, p=0·0004), day care intravenous hydration (82·5 versus 38·6% <0·0001) and in-patient admission (55·0 versus 18·2%; p=0·0004). The 2-year LRC, DFS and OS in weekly versus 3-weekly arm were: 70 versus 61·4% (p=0·406); 67·5 versus 56·8% (p=0·314); 67·5 versus 61·4% (p=0·558), respectively. The median time to LRR, DFs and OS was not reached.ConclusionsWeekly cisplatin is comparable with 3-weekly cisplatin in terms of compliance, disease control and survival, but with increased grade 3 mucositis and higher admissions for supportive care.


2008 ◽  
Vol 22 (6) ◽  
pp. 1155-1163 ◽  
Author(s):  
Jochen H. Lorch ◽  
Marshall R. Posner ◽  
Lori J. Wirth ◽  
Robert I. Haddad

Cancer ◽  
2010 ◽  
Vol 116 (19) ◽  
pp. 4533-4540 ◽  
Author(s):  
Heather E. Newlin ◽  
Robert J. Amdur ◽  
Charles E. Riggs ◽  
Christopher G. Morris ◽  
Jessica M. Kirwan ◽  
...  

Oral Oncology ◽  
2022 ◽  
Vol 125 ◽  
pp. 105709
Author(s):  
Vijay Patil ◽  
Netra Ghandade ◽  
Vanita Noronha ◽  
Nandini Menon ◽  
Kumar Prabhash

Head & Neck ◽  
2004 ◽  
Vol 27 (1) ◽  
pp. 36-43 ◽  
Author(s):  
Gabriele K. Beckmann ◽  
Florian Hoppe ◽  
Leo Pfreundner ◽  
Michael P. Flentje

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 16500-16500
Author(s):  
C. J. Calfa ◽  
M. Escalon ◽  
S. Zafar ◽  
E. Lopez ◽  
V. Patel ◽  
...  

16500 Background: Self identified racial groups share an unequal burden of head and neck cancer . Recent evidence suggests that outcome among races is different and the causes are multifactorial. Nonetheless, differences among ethnic groups have not been reported. Herein, we decided to analyze differences in treatment response and outcome among our white and Hispanic patient population treated for locally advanced head and neck cancer. Methods: Patients were identified using the tumor registry. We reviewed retrospectively the data from medical records. 100 white Hispanics (WH) and 50 white non-Hispanics (WNH) diagnosed with locally advanced head and neck cancer and treated at our institution from 2004 to 2005, were eligible for the study. Standard statistical analysis, including Kaplan-Meier survival curve and Cox proportional hazard models were used. P value of <0.05 was considered for statistical significance. Results: Preliminary results reveal that, in our study population, median age at diagnosis, gender, performance status (ECOG 0–2) and squamous cell histology did not differ significantly between the two groups. Stage 4 at diagnosis was more commonly observed in Hispanics as opposed to WNH (85.7% vs 68.6%) (P = 0.1). Surgery was more commonly used as an initial treatment option in Hispanics than WNH (42.8% vs 28.6%) (P = 0.18) while chemotherapy was less likely to be used (78.6% vs. 91.4%) (P = 0.15). Hispanics were more likely to smoke than WNH (P = 0.0003) and were equally exposed to chronic alcohol use. Patients from the Hispanic group were more likely to respond to therapy than whites by Chi-squared analysis but this difference was not statistically significant (P = 0.09). No differences were seen in disease free survival. Kaplan-Meier estimate of median overall survival was 16 months for Hispanics vs. 25 months for whites but this difference did not reach statistical significance (P = 0.26). Final analysis will be available at the time of the annual meeting. Conclusion: In our experience, a trend for decrease overall survival was noted in the Hispanic ethnic group. This may be in part due to more advanced stage at presentation. Nonetheless, in order to definitively answer this question, further research is warranted. No significant financial relationships to disclose.


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