Clinical outcomes and prognostic factors in recurrent and/or metastatic head and neck cancer patients treated with chemotherapy plus cetuximab as first-line therapy in a real-world setting

Depenni, Roberta; Rocca, Maria Cossu; Ferrari, Daris; Azzarello, Giuseppe; Baldessari, Cinzia; Alù, Massimiliano; Nolè, Franco; Codecà, Carla; Boscolo, Giorgia; Piccininni, Marco; Cavalieri, Stefano; Bossi, Paolo

doi:10.1016/j.ejca.2019.03.022

Cited by 20 publications

(15 citation statements)

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“…Median PFS for PFE vs. PF was not statistically significant in our report. Regarding median PFS and OS with platinum-based chemotherapy and cetuximab, similar results to ours were reported by other real-world studies (10)(11)(12)(13)(14).…”

Section: Discussionsupporting

confidence: 91%

“…This is probably due to the appropriate selection of patients for systemic therapy in our daily practice. In a real-world population ( 14), one third of patients were platinum resistant, which carries poor prognosis (10,11,14). In our study, 4 (6%) patients were platinum resistant and died within three months of therapy.…”

Section: Univariate Analysismentioning

confidence: 48%

“…Due to poor prognosis of R/M HNSCC, data on possible prognostic factors affecting OS and PFS are of great clinical value (10)(11)(12)(13)(14). In our study, favourable prognostic factors for OS were achieving an objective response to therapy and receiving a subsequent line of treatment after progression upon first-line treatment.…”

Section: Discussionmentioning

confidence: 70%

“…Depenni et al (10) found independent unfavourable prognostic factors for OS and PFS in PFE regimen PS >0, presence of residual tumour at the primary site, platinum resistance and lack of objective response. Magnes et al (11) reported PS >1, leucocytosis and increased C-reactive protein, treatment-free interval <12 months and less intensive chemotherapy as prognostic factors for OS.…”

Section: Discussionmentioning

confidence: 99%

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Outcome of patients with recurrent/metastatic squamous cell head and neck cancer treated with platinum‑based chemotherapy with or without cetuximab in real‑world practice

2021

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Patients with recurrent or metastatic squamous cell head and neck cancer (R/M SCHNC) exhibit a poor prognosis with a median overall survival (OS) time of <1 year. Platinum-based chemotherapy with or without cetuximab has been the standard of care in the last decade. The aim of the current retrospective study was to evaluate the outcome and tolerability of treatment in patients with R/M SCHNC receiving platinum/5-fluorouracil/cetuximab (PFE) chemotherapy compared with platinum/5-fluorouracil (PF) chemotherapy in daily clinical practice. A retrospective analysis was performed using the data of patients treated at the Institute of Oncology Ljubljana between April 2008 and May 2018. Progression-free survival (PFS) and OS were calculated with the Kaplan-Meier method and compared with the log-rank test. Multivariate regression Cox analysis was used to determine independent prognostic factors. A total of 67 patients were treated at the aforementioned Institute: 34 patients received the PF and 33 the PFE regimen. The mean age of patients was 54.6 years and 91% of patients were male. Median PFS time was 6.6 vs. 7.1 months for the PF vs. PFE groups, respectively (P=0.852). Median OS time was 9.6 vs. 11.5 months for the PF vs. PFE groups, respectively (P=0.029). The prognostic factor for PFS was partial remission [hazard ratio (HR), 0.32; 95% CI, 0.15-0.70; P=0.004]. Prognostic factors for OS were partial remission (HR, 0.15; 95% CI, 0.06-0.38; P<0.001) or stable disease (HR, 0.28; 95% CI, 0.13-0.64; P=0.002), and a subsequent line of treatment upon progression (HR, 0.28; 95% CI, 0.15-0.52; P<0.001). In the PFE group, 15.4% of patients had a grade >2 infusion reaction to cetuximab and 27.3% had grade 3 skin rash. There were no differences in diarrhoea, hypomagnesaemia, infections and febrile neutropenia; however, the mortality on active treatment was high (13.4%). In conclusion, patients treated with PFE had similar PFS, but improved OS compared with patients treated with the PF protocol. The proportion of patients who died under treatment due to disease progression and toxicity was high in both treatment arms. A thorough selection of patients for this treatment is crucial.

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Section: Discussionsupporting

confidence: 91%

Section: Univariate Analysismentioning

confidence: 48%

Section: Discussionmentioning

confidence: 70%

Section: Discussionmentioning

confidence: 99%

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Outcome of patients with recurrent/metastatic squamous cell head and neck cancer treated with platinum‑based chemotherapy with or without cetuximab in real‑world practice

2021

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“…In contrast, the statistically significant effects of platinum sensitivity status and ECOG PS on OS in this analysis are to be expected. Platinum sensitivity has been previously reported to be associated with better outcomes, 22,23 and ECOG PS has been found to be an important prognostic factor of OS in patients with SCCHN. [24][25][26][27] The survival outcomes in nivolumab-treated patients with SCCHN from this pooled analysis are in line with those from other studies evaluating nivolumab in this population.…”

Section: Discussionmentioning

confidence: 95%

Pooled analysis of nivolumab treatment in patients with recurrent/metastatic squamous cell carcinoma of the head and neck in the United States and Germany

et al. 2021

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Background: In the Phase-III clinical trial, CheckMate 141, nivolumab significantly improved survival versus standard of care in patients with platinumrefractory recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). Methods: This pooled analysis investigated the real-world effectiveness of nivolumab, following prior platinum-based therapy, in patients with R/M SCCHN from the United States (US) Flatiron Health database and German HANNA prospective observational study. Results: Overall, 782 patients (56% US; 44% Germany) were included. Median overall survival (OS) was 8.71 months, and progression-free survival was 4.11 months. Eastern Cooperative Oncology Group Performance Status 0 or 1, platinum sensitivity, and older age were associated with longer OS, in which number of prior lines of therapy had no significant effect. Conclusion: These findings demonstrate survival benefits of nivolumab in patients with R/M SCCHN in the real-world setting. The observed real-world effectiveness of nivolumab aligns with the efficacy of nivolumab in CheckMate 141.

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Early recurrence, time‐to‐recurrence, and recurrence patterns: Assessing their impact on survival outcomes in head and neck squamous cell carcinoma (R/M‐HNSCC) patients treated with first line platinum‐based chemotherapy

Pitakpaiboonkul,

Jiarpinitnun,

Pattaranutaporn

et al. 2024

Cancer Medicine

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BackgroundR/M‐HNSCC patients typically receive 1L platinum‐based chemotherapy with pembrolizumab or cetuximab. However, the outcomes for patients with early recurrence (<6 months) remain unclear due to their exclusion from most 1L studies. This study aimed to assess the impact of time‐to‐recurrence intervals (TTRI) and recurrence patterns on the survival of R/M‐HNSCC patients.MethodsWe identified non‐curable R/M‐HNSCC patients at our institution from 1/2008 through 6/2020. We analyzed the outcomes of early recurrent patients who received 1L systemic treatment, with different TTRIs and recurrence patterns.ResultsOur study included 234 eligible patients. The majority (47%) experienced early recurrence (<6 months), while 22%, 20%, and 11% had recurrences at 6–12 months, >12 months, and de novo metastasis, respectively. The platinum‐based regimen was the most commonly used chemotherapy (86%), with cetuximab and immunotherapy utilized in 3% and 5% of cases, respectively. Significant differences in PFS and OS were observed among TTRI groups. For patients with early recurrence, both platinum‐doublet and monotherapy treatments significantly improved OS. Locoregional recurrence (47%) was the most common, followed by distant metastasis (22%) and both (20%). Recurrence patterns were significantly associated with OS but not with PFS. In multivariate analysis, TTRI ≥12 months significantly correlated with improved PFS (HR 0.51; p = 0.004) and OS (HR 0.58; p = 0.009), whereas recurrent pattern did not.ConclusionTTRI significantly influenced the survival, while recurrence patterns did not. In our study, the retrospective design limited our ability to definitively establish whether early recurrent R/M‐HNSCC patients would benefit more from platinum‐doublet. Despite poor prognosis, early recurrent patients benefited from 1L systemic treatments. Given the variation in prognoses, TTRI should be considered a stratification factor in future clinical trials.

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Clinical outcomes and prognostic factors in recurrent and/or metastatic head and neck cancer patients treated with chemotherapy plus cetuximab as first-line therapy in a real-world setting

Cited by 20 publications

References 15 publications

Outcome of patients with recurrent/metastatic squamous cell head and neck cancer treated with platinum‑based chemotherapy with or without cetuximab in real‑world practice

Outcome of patients with recurrent/metastatic squamous cell head and neck cancer treated with platinum‑based chemotherapy with or without cetuximab in real‑world practice

Pooled analysis of nivolumab treatment in patients with recurrent/metastatic squamous cell carcinoma of the head and neck in the United States and Germany

Early recurrence, time‐to‐recurrence, and recurrence patterns: Assessing their impact on survival outcomes in head and neck squamous cell carcinoma (R/M‐HNSCC) patients treated with first line platinum‐based chemotherapy

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