Chemotherapy Options for Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck

2006 ◽  
Vol 24 (17) ◽  
pp. 2644-2652 ◽  
Author(s):  
A. Dimitrios Colevas

The purpose of this review is to provide readers with guidance concerning treatment of patients with advanced, recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) in the context of clinical trial data. We discuss issues surrounding the treatment of patients with SCCHN, with an emphasis on recommendations based on results from phase II and III clinical trials published since 1980. Many options exist for the treatment of patients with SCCHN. The most important decisions involve determining which patients are in need of treatment and which are most likely to benefit from treatment. Although many chemotherapy treatments have been shown to induce responses, survival improvement remains an unfulfilled goal. Definitive data do not exist on the effects of chemotherapy on quality of life or progression-free survival as measures of clinical benefit in this setting. Performance status, history of prior treatment, extent of tumor, and need for palliation are the most important factors in the decision to treat a patient with chemotherapy for incurable SCCHN. Single-agent treatment with conventional doses of methotrexate remains a standard for most patients with advanced, recurrent or metastatic SCCHN. Cisplatin plus fluorouracil, cisplatin plus a taxane, and single-agent taxane are the most widely studied alternatives. There is a need for further trials with end points other than overall survival or tumor response in this patient population. Guidelines for patient selection and treatment options are provided.

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e17005-e17005
Author(s):  
B. Hough ◽  
M. Posner ◽  
C. Chung ◽  
J. Hainsworth ◽  
J. Horan ◽  
...  

e17005 Background: Given the limited efficacy and relative toxicity of chemotherapy for metastatic or recurrent squamous cell carcinoma of the head and neck, further research is needed to both increase the efficacy and decrease the toxicity of treatment. OSI-7904L is a novel liposomal formulation of a non-competitive thymidylate synthase inhibitor. In a phase I study, 12 mg/m2 dosing given every 21 days was both feasible and well tolerated. Methods: This multi-center, two-stage, phase II trial was designed to assess the efficacy and toxicity of OSI-7904L in patients with advanced, refractory SCCHN. A total of 41 patients were to be enrolled by completion of stage II. Enrollment was limited to patients with histologically proven squamous histology, locally recurrent and/or metastatic disease, with no more than one prior chemotherapy regimen. Patients were required to have a performance status of ≤ 2, predicted life expectancy of at least three months and adequate hematopoietic, hepatic and renal function. Efficacy was assessed according to RECIST guidelines, and toxicity was evaluated per CTC AE 3.0. Results: Ten patients enrolled in stage 1. Median age was 60 (range 42–66). Nine were evaluable for response assessment with one withdrawn after one cycle due to a grade 4 papular rash. There were no objective responses while 4 of the 10 patients had stable disease during their first restaging. Median time to progression was 2.5 months for the 9 evaluable patients. Besides the one grade 4 dermatologic reaction, other toxicities were grade 3 fatigue and dehydration, and grade 2 anorexia. Assuming an expected 20% response rate required to initiate enrollment in stage II, the probability of the tenth patient being a responder was less than 3%, thus the study was closed due to lack of response in this population. Conclusions: OSI-7904L was well tolerated similar to the phase I data, but did not demonstrate efficacy in metastatic or recurrent HNSCC patients. Further study of this drug as a single-agent with the current dosing regimen is not recommended. [Table: see text]


2017 ◽  
Vol 157 (6) ◽  
pp. 995-997 ◽  
Author(s):  
Poorni M. Manohar ◽  
Eli Sapir ◽  
Emily Bellile ◽  
Paul L. Swiecicki ◽  
Alexander T. Pearson ◽  
...  

Due to the high incidence of recurrent squamous cell carcinoma of the head and neck and the toxicity profile of current salvage regimens, there is a need for tolerable and effective treatment options. We performed a retrospective matched case series to report our experience with recurrent high-risk patients who received capecitabine (CAP) therapy in the adjuvant setting after salvage therapy. The 5-year recurrence-free survival rates for the CAP and control cohorts were 54% (95% CI, 0.27%-0.75%) and 27% (95% CI, 0.09%-0.50%), respectively. Multivariable Cox modeling showed a significant improvement in recurrence-free survival in the CAP cohort (hazard ratio, 0.19; 95% CI, 0.04-0.92; P = .0392). While this was a respective analysis that could not control for all variables, these exploratory findings offer insights that may inform a prospective study to determine CAP efficacy.


Author(s):  
Waseem Abbas ◽  
Saurabh Gupta ◽  
Vineeta Goel ◽  
Ranga R. Rao ◽  
Promila Pankaj ◽  
...  

Abstract Background Recurrent metastatic head and neck squamous cell carcinoma (HNSCC) patients carry a poor prognosis and have limited therapeutic options. In the randomized phase-3 trial CheckMate 141, nivolumab showed benefit in overall survival (OS) with manageable toxicity. Nivolumab is available for clinical practice since 2017 in India. The aim of this study is to evaluate the efficacy and safety of nivolumab in real-world settings in India. Materials and Methods This is a retrospective, single-center study on the use of nivolumab with advanced or metastatic HNSCC in India. Eligible patients had histologically confirmed, recurrent squamous cell carcinoma of the head and neck (including metastatic disease) of the oral cavity, pharynx, or larynx that was not amenable to curative treatment, tumor progression, or recurrence after the administration of platinum-containing chemotherapy administered as adjuvant therapy or in the context of primary or recurrent disease. We assessed demographics, safety (the Common Terminology Criteria for Adverse Events Version 4.0), response evaluation (the Response Evaluation Criteria in Solid Tumors Version 1.1), progression-free survival (PFS), and OS. Results Among patients with platinum-refractory, recurrent HNSCC, and treatment with nivolumab resulted in median PFS of 2 months and median OS of 5 months, which is inferior to what was seen in CheckMate 141. Fifteen of 20 patients (75%) had progressive disease, 3 (15%) showed a partial response, and 2 (10%) had stable disease. Conclusion Nivolumab was well tolerated in our study with fewer toxic effects, and an inferior median survival was reached as compared with CheckMate 141 in platinum refractory, recurrent HNSCC patients treated with nivolumab because 90% of patients in our study received nivolumab as second-line therapy after progression. Our study encourages the use of nivolumab in this population.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e16044-e16044 ◽  
Author(s):  
Delphine Borchiellini ◽  
Charlotte Dupuis ◽  
Jocelyn Gal ◽  
Benjamin Lallemant ◽  
Marc Alfonsi ◽  
...  

e16044 Background: Induction chemotherapy with docetaxel, cisplatin, and 5FU (TPF) followed by cisplatin-based chemoradiation (CRT) is a valid option for the treatment of advanced head and neck squamous cell carcinoma (LASCC). Radiotherapy (RT) associated with cetuximab (RT-cetux) is superior to RT alone and has less systemic toxicity than CRT. Recent data suggest RT-cetux could be an alternative treatment to CRT after induction TPF. The aim of this study was to report the outcome of these pts in clinical practice. Methods: A multicentric retrospective analysis was conducted in LASCC pts treated with induction TPF (T 75mg/m2 day 1, P 75mg/m2 day 1, F 750mg/m2/d day 1 to 4 – q3w), followed by CRT (cisplatin 100mg/m2 – q3w) or RT-cetux (400mg/m2 loading dose and 250mg/m2 – q1w). Exploratory endpoints were progression-free survival (PFS), cancer specific survival (CSS) and overall survival (OS). Results: 164 pts treated from October 2005 to June 2010 were eligible. 113 pts had TPF followed by CRT and 51 pts had TPF followed by RT-cetux. Clinical characteristics were similar in each group, regarding gender (men 84% vs 92%), mean age (56 vs 57 yrs), BMI (23.4 vs 23 kg/m2), alcohol consumption under treatment (41% vs 49%), non laryngeal tumor site (77% vs 73%), T3-T4 tumor size (84% vs 80%) and N+ status (71% vs 77%). There was a difference in performance status 0 and 1 between pts in CRT group (73% and 26%) and RT-cetux group (47% and 51%) (p=0.005). 2-yr PFS rate was 68% in CRT group vs 42% in RT-cetux group (p=0.002). After a median follow-up of 23 months, the median PFS was not reached in CRT pts vs 13 months (95% CI : 8.1-17.9 months) for RT-cetux group. At 2 years, CSS and OS rate was 84% and 78% vs 54% and 50%, respectively (p<0.0001). Median CSS ans OS were not reached in CRT group as compared to 25 months (95% CI : 14.6-35.4 months) and 23 months (95% CI : 10.7-35.3 months) in the RT-cetux group, respectively. Conclusions: In daily practice, outcome after induction TPF for LASCC pts seems to be superior with standard CRT than RT-cetux. The higher proportion of PS 1 pts in the RT-cetux group could explain this difference. These data suggest that selection of pts should be carefully considered.


Author(s):  
Ananya Pareek ◽  
Apurva A. Patel ◽  
Mukesh Kumar ◽  
Philip G. Kuttikat ◽  
Harshavardhan Annadanam ◽  
...  

Abstract Background Immunotherapy is a proven therapeutic option in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) after platinum therapy. At present, there are no published Indian data regarding administration of nivolumab in this setting. Aim The aim of this study is to retrospectively evaluate the efficacy and toxicity of nivolumab in R/M HNSCC among Indian patients who progressed after one or more lines of chemotherapy, including platinum agents. Methods All patients of R/M HNSCC who received nivolumab between 2/6/2018 to 31/3/2020 were assessed retrospectively for the efficacy and toxicity of nivolumab therapy. Statistical Analysis All the data analysis was performed using IBM SPSS Statistics for Windows, version 25 (IBM Corp., Armonk, N.Y., USA). Descriptive analysis was performed to obtain baseline characteristic of the study sample. Survival analysis was done using the Kaplan–Meier method. Results Nivolumab therapy was tolerated well, with no new safety concerns, except one (8.3%) patient experienced grade ¾ toxicity (gastrointestinal). The clinical benefit rate (CBR) was found to be 66.7%. The median progression-free survival (PFS) was 3 months (95% CI; 2.093–3.907), and median overall survival (OS) was 8 months (95% CI; 3.731–12.269) from the date of first dose of nivolumab. Conclusions In our study, efficacy and toxicity were comparable with international data with no new safety concerns. Nivolumab emerged as an astonishing treatment option with tolerable toxicity profile in patients with R/M HNSCC postplatinum therapy, although limited treatment options are available at present.


2000 ◽  
Vol 18 (7) ◽  
pp. 1458-1464 ◽  
Author(s):  
Branislav Jeremic ◽  
Yuta Shibamoto ◽  
Biljana Milicic ◽  
Nebojsa Nikolic ◽  
Aleksandar Dagovic ◽  
...  

PURPOSE: To investigate whether the addition of cisplatin (CDDP) to hyperfractionation (Hfx) radiation therapy (RT) offers an advantage over the same Hfx RT given alone in locally advanced (stages III and IV) squamous cell carcinoma of the head and neck. PATIENTS AND METHODS: One hundred thirty patients were randomized to receive either Hfx RT alone to a tumor dose of 77 Gy in 70 fractions in 35 treatment days over 7 weeks (group I, n = 65) or the same Hfx RT and concurrent low-dose (6 mg/m2) daily CDDP (group II, n = 65). RESULTS: Hfx RT/chemotherapy offered significantly higher survival rates than Hfx RT alone (68% v 49% at 2 years and 46% v 25% at 5 years; P = .0075). It also offered higher progression-free survival (46% v 25% at 5 years; P = .0068), higher locoregional progression-free survival (LRPFS) (50% v 36% at 5 years; P = .041), and higher distant metastasis-free survival (DMFS) (86% v 57% at 5 years; P = .0013). However, there was no difference between the two treatment groups in the incidence of either acute or late high-grade RT-induced toxicity. Hematologic high-grade toxicity was more frequent in group II patients. CONCLUSION: As compared with Hfx RT alone, Hfx RT and concurrent low-dose daily CDDP offered a survival advantage, as well as improved LRPFS and DMFS.


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