Activity of weekly paclitaxel−cetuximab chemotherapy in unselected patients with recurrent/metastatic head and neck squamous cell carcinoma: prognostic factors

Bernad, Isabel Pajares; Trufero, Javier Martínez; Urquizu, Lourdes Calera; Pazo-Cid, Roberto; Miguel, Ana; Agustín, Ma J.; Lanzuela, M.; Antón, A.

doi:10.1007/s12094-016-1604-z

Cited by 15 publications

(15 citation statements)

References 35 publications

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“…Common adverse events. PFS of 3.9-7.7 months, and median OS of 7.6-16.8 months(8)(9)(10)(11)(12)(13)(14)(15)(16). The results of our study are consistent with those of previous studies.…”

supporting

confidence: 92%

“…Recently, the combination of taxanes and Cmab, for example, exchanging 5-FU for taxanes in the Extreme regimen, has drawn attention (7). Cmab and paclitaxel combination therapy (Cmab-PTX), first reported by Hitt et al (8), is one such combination, and some studies have reported that Cmab-PTX has good efficacy for R/MHNSCC patients (7)(8)(9)(10)(11)(12)(13)(14)(15)(16). However, the prognostic factors associated with Cmab-PTX have been inadequately reported (9,10).…”

mentioning

confidence: 99%

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Weekly Cetuximab and Paclitaxel for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Fushimi

Baba

Masubuchi

et al. 2020

In Vivo

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Background/Aim: Head and neck cancers account for 8% of all cancer cases worldwide. However, identifying the optimal treatment for recurrent or metastatic head and neck cancer (R/MHNSCC) has been challenging. The aim of this study was to evaluate the efficacy, safety, and prognostic factors of the outcome of patients with R/MHNSCC who were treated with weekly cetuximab and paclitaxel (Cmab-PTX). Patients and Methods: The records of R/MHNSCC patients who were treated with Cmab-PTX in our institution between June 2013 and September 2017 were collected. We analyzed Overall survival (OS), progression-free survival (PFS), prognostic factors and adverse events. Results: The records of 59 patients treated with Cmab-PTX were analyzed. The median PFS was 5.7 months, and the median OS was 11.8 months. Patients who had been administered cetuximab previously had shorter PFS and OS than those who had not. Conclusion: Cmab-PTX may be considered as a treatment option in head and neck R/MHNSCC patients.

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“…Common adverse events. PFS of 3.9-7.7 months, and median OS of 7.6-16.8 months(8)(9)(10)(11)(12)(13)(14)(15)(16). The results of our study are consistent with those of previous studies.…”

supporting

confidence: 92%

mentioning

confidence: 99%

Weekly Cetuximab and Paclitaxel for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Fushimi

Baba

Masubuchi

et al. 2020

In Vivo

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“… 10 Especially, 5-FU was associated with cardiac toxicity and other life-threatening side effects, as well as with high mortality rates. 9 - 11 …”

Section: Introductionmentioning

confidence: 99%

RETRACTED: Efficacy and Safety of Cetuximab Plus Cisplatin Alone or in Combination With Paclitaxel in Patients With Head and Neck Squamous Cell Carcinoma: A Randomized Trial

Zheng

Dou

et al. 2021

Cancer Control

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Objectives: The aim of this study was to assess the clinical usefulness of cetuximab and cisplatin alone or in combination with paclitaxel as the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Methodology: Three hundred patients with confirmed HNSCC from 20 different hospitals were included in this study. Patients in group I underwent a 2-hour infusion of 400 mg/m2 cetuximab (day 1), followed by a 1-hour infusion of 250 mg/m2 cetuximab weekly and 1-hour infusion of 100 mg/m2 cisplatin (days 1 and 21) per treatment cycle. Patients in group II were treated with a combination of cetuximab, cisplatin, and paclitaxel. Patients received 6 cycles of 175 mg/m2 paclitaxel given on days 1 and 21. The primary outcome of the study was progression-free survival (PFS); overall survival (OS) and objective response rate (ORR) were the secondary endpoints. Results: The median PFS was 5 months and 8 months for patients in groups I and II, respectively (HR, 0.93; 95% CI, 0.85–1.78; P > 0.05). Similarly, we found no significant differences in OS between the 2 groups (median OS, 13 vs. 11 months, respectively; HR, 0.67; 95% CI, 0.42–1.43; P = 0.198). Moreover, we observed no significant difference in ORR between the 2 groups (ORR, 63.3% vs 69.9%, respectively; HR, 0.87; 95% CI, 0.36–1.67; P = 0.231). Conclusions: The combination of paclitaxel with cetuximab and cisplatin did not improve patient outcomes compared to cetuximab plus cisplatin alone. Therefore, the 2-drug regimen could be used as first-line treatment in patients with recurrent or metastatic HNSCC.

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“…A cetuximab-taxane regimen could confer benefit in this patient population. Indeed, the combination of cetuximab plus docetaxel or paclitaxel has been shown to have a manageable safety profile and promising efficacy in various prospective and retrospective studies of patients with either first-line or platinum-refractory R/M SCCHN (Table 4) (2, 58–60). Although these studies had small numbers of enrolled patients and were single arm or retrospective, the results suggested that patient selection for cetuximab-plus-taxane combinations in the settings of cisplatin/carboplatin unsuitability or poor PS may result in high ORRs and disease control in certain poor-prognosis populations.…”

Section: Uses Of Cetuximab Plus a Taxanementioning

confidence: 99%

The Evolving Role of Taxanes in Combination With Cetuximab for the Treatment of Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck: Evidence, Advantages, and Future Directions

et al. 2019

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The addition of cetuximab to platinum-based chemotherapy (cisplatin or carboplatin plus 5-fluorouracil [5-FU]), followed by maintenance cetuximab until disease progression (EXTREME), resulted in the first regimen to yield significantly improved survival outcomes in the first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) in over 30 years. Currently, the EXTREME regimen is a guideline-recommended treatment in the first-line R/M setting, and, therefore, it is used as a control arm in all new first-line, phase 3 immunotherapy trials. More recently, new checkpoint inhibitor approaches have emerged and are changing the treatment landscape for PD-L1–positive patients with R/M SCCHN. Additionally, alternative chemotherapy backbones in R/M SCCHN are continually investigated. Replacing 5-FU with a taxane in the EXTREME regimen seeks to take advantage of the potential immunogenic and proapoptotic synergy between cetuximab and docetaxel or paclitaxel. These cetuximab-, platinum-, and taxane-based treatments have demonstrated promising survival results and cytoreductive properties in single-arm studies. Thus, these combination treatments may be of importance to patients with high tumor burden and dangerous site involvements (e.g., causing bleeding, suffocation, dysphagia, or ulceration), in whom symptom relief is a key treatment goal. TPExtreme is the first large, randomized trial comparing a cetuximab, platinum, and taxane combination regimen with EXTREME. Currently, the substitution of 5-FU with a taxane is a feasible and clinically beneficial option for patients with contraindications to 5-FU. The TPEx regimen appears to be a new option in first-line R/M SCCHN, with a shorter time on CT and significantly lower toxicity than the EXTREME regimen. For patients with R/M disease in whom further cisplatin- or carboplatin-based treatment is unsuitable, or whose disease has already progressed on first-line R/M therapy, treatment options such as cetuximab plus a taxane, which capitalize on the combinative ability of the 2 agents, can be considered. Notably, it is as of yet unknown what second-line treatments may be suitable to follow a checkpoint inhibitor-based first-line therapy.

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Activity of weekly paclitaxel−cetuximab chemotherapy in unselected patients with recurrent/metastatic head and neck squamous cell carcinoma: prognostic factors

Cited by 15 publications

References 35 publications

Weekly Cetuximab and Paclitaxel for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Weekly Cetuximab and Paclitaxel for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

RETRACTED: Efficacy and Safety of Cetuximab Plus Cisplatin Alone or in Combination With Paclitaxel in Patients With Head and Neck Squamous Cell Carcinoma: A Randomized Trial

The Evolving Role of Taxanes in Combination With Cetuximab for the Treatment of Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck: Evidence, Advantages, and Future Directions

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