Abstract
Previously, we conducted a randomized phase III trial of TPF (docetaxel, cisplatin, and 5-fluorouracil) induction chemotherapy in surgically managed locally advanced oral squamous cell carcinoma (OSCC) and found no improvement in overall survival. This study reports long-term follow-up results from our initial trial. All patients had clinical stage III or IVA locally advanced OSCC. In the experimental group, patients received two cycles of TPF induction chemotherapy (75mg/m2 docetaxel d1, 75mg/m2 cisplatin d1, and 750mg/m2/day 5-fluorouracil d1-5) followed by radical surgery and post-operative radiotherapy; in the control group, patients received upfront radical surgery and post-operative radiotherapy. The primary endpoint was overall survival. Among 256 enrolled patients with a median follow-up of 70 months, estimated 5-year overall survival, disease-free survival, locoregional recurrence-free survival, and distant metastasis-free survival rates were 61.1%, 52.7%, 55.2%, and 60.4%, respectively. There were no significant differences in survival rates between experimental and control groups. However, patients with favorable pathologic responses had improved outcomes compared to those with unfavorable pathologic responses and to those in the control group. Although TPF induction chemotherapy did not improve long-term survival compared to surgery upfront in patients with stage III and IVA OSCC, a favorable pathologic response after induction chemotherapy may be used as a major endpoint and prognosticator in future studies. Furthermore, the negative results observed in this trial may be represent type II error from an underpowered study. Future larger scale phase III trials are warranted to investigate whether a significant benefit exists for TPF induction chemotherapy in surgically managed OSCC.
Highlights
The majority of patients with oral squamous cell carcinoma (OSCC) present with locally advanced disease [1, 2]
In clinical trials TAX323 and TAX324, which investigated non-surgical management of head and neck squamous cell carcinomas (HNSCC), induction chemotherapy with docetaxel, cisplatin and 5-fluorouracil (TPF) was found to improve survival compared to induction cisplatin and 5-fluorouracil (PF) [8, 9]
The clinical trials DeCIDE and PARADIGM failed to demonstrate a benefit of TPF induction chemotherapy in HNSCC when given prior to concurrent chemoradiotherapy compared to chemoradiotherapy upfront [11, 12]
Summary
The majority of patients with oral squamous cell carcinoma (OSCC) present with locally advanced disease [1, 2]. The use of induction chemotherapy prior to definitive treatment for management of locally advanced head and neck squamous cell carcinomas (HNSCC) is controversial [5,6,7]. Ghi et al recently reported an improvement in overall survival (OS) in patients treated with induction TPF followed by concurrent treatment (cetuximab/ radiotherapy or PF/radiotherapy) compared to concurrent treatment upfront [10]. The clinical trials DeCIDE and PARADIGM failed to demonstrate a benefit of TPF induction chemotherapy in HNSCC when given prior to concurrent chemoradiotherapy compared to chemoradiotherapy upfront [11, 12]. This study did not demonstrate an improvement in OS in patients that received induction TPF compared to surgery upfront [13]. We report the long-term follow-up results of this trial
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