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Paclitaxel, cisplatin, leucovorin, and continuous infusion fluorouracil followed by concomitant chemoradiotherapy for locally advanced squamous cell carcinoma of the head and neck

A hellenic cooperative oncology group phase II study

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Abstract

The primary objective of this phase II study was to access the complete response (CR) rate to a new innovative induction regimen in patients with locally advanced head and neck cancer (LA-HNC). From October 2000 until October 2003 a total of 38 eligible patients (33 men and 5 women) entered the study. The large majority of them presented with a performance status of 0–1 and with clinical stage IV disease. Treatment consisted of three cycles of induction chemotherapy (IC) with paclitaxel 175 mg/m2 in a 3-h infusion on d 1, leucovorin (LV) 200 mg/m2 over 20 min immediately followed by FU 400 mg/m2 bolus and then 600 mg/m2 as a 24-h continuous infusion on d 1 and 2 and a cisplatin 75 mg/m2 over 1-h infusion on d 2 every 3 wk. This was then followed by radiation (70 Gy) and weekly cisplatin 40 mg/m2. After the completion of IC, 6/38 (16%) patients had CR. The CR rate was increased to 66% post-concomitant chemoradiotherapy (CCRT). Neutropenia (37.5%), pain (62%), nausea/vomiting (21%), and alopecia (79%) were the most frequent side effects during IC. The most pronounced toxicities during chemoradiotherapy were stomatitis (62.5%) and xerostomia (53%). Median time to progression was 11.0 mo and median survival 16.7 mo. One- and 2-yr survival rates were 73% and 38%, respectively. In conclusion, this novel induction regimen is active, is well tolerated, and can be successfully followed by CCRT with weekly cisplatin. CCRT should remain standard treatment for patients with LA-HNC. Novel induction combinations, such as that reported in the present study, should be evaluated in combination with CCRT only in the context of clinical trials.

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Authors and Affiliations

  1. Department of Medical Oncology, “PAPAGEORGIOU” General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Macedonia, Greece

    George Fountzilas MD (Head), Anna Kalogera-Fountzila, Maria Karina, Angelos Nikolaou, Sophia Karanastassi & John Daniilidis

  2. University of Ioannina School of Medicine, Ioannina

    Christos Tolis, Periklis Tsekeris & Nicholas Pavlidis

  3. “Papageorgiou” Hospital, Aristotle University of Thessaloniki, Thessaloniki

    Despina Misailidou

  4. “Agii Anargiri” Cancer Hospital, Athens

    Epaminondas Samantas

  5. “Rio” Hospital, University of Patras School of Medicine, Patras

    Thomas Makatsoris

  6. “Agios Savvas” Cancer Hospital, Athens

    Eleni Athanassiou

  7. “Errikos Dunant” Hospital, Athens

    Dimosthenis Skarlos

  8. Department of Clinical Therapeutics, “Alexandra” Hospital, University of Athens School of Medicine, Athens, Greece

    Aristotelis Bamias

  9. Department of Radiotherapy, Klinikum Offenbach, Offenbach, Germany

    Nikolas Zamboglou

  10. 2nd Department of Internal Medical-Propaedeutic, University of Athens School of Medicine, “Attikon” Hospital, Athens, Greece

    Theofanis Economopoulos

Authors
  1. George Fountzilas MD
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  2. Christos Tolis
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  3. Anna Kalogera-Fountzila
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  6. Maria Karina
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  7. Angelos Nikolaou
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  9. Thomas Makatsoris
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  10. Eleni Athanassiou
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  11. Dimosthenis Skarlos
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  12. Aristotelis Bamias
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  15. Sophia Karanastassi
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Correspondence to George Fountzilas MD.

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Fountzilas, G., Tolis, C., Kalogera-Fountzila, A. et al. Paclitaxel, cisplatin, leucovorin, and continuous infusion fluorouracil followed by concomitant chemoradiotherapy for locally advanced squamous cell carcinoma of the head and neck. Med Oncol 22, 269–279 (2005). https://doi.org/10.1385/MO:22:3:269

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  • DOI: https://doi.org/10.1385/MO:22:3:269

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