European Archives of Oto-Rhino-Laryngology

, Volume 266, Issue 8, pp 1291–1300 | Cite as

Induction chemotherapy with paclitaxel and cisplatin followed by radiotherapy for larynx organ preservation in advanced laryngeal and hypopharyngeal cancer offers moderate late toxicity outcome (DeLOS-I-trial)

  • Andreas Dietz
  • Volker Rudat
  • Jens Dreyhaupt
  • Maria Pritsch
  • Florian Hoppe
  • Rudolph Hagen
  • Leo Pfreundner
  • Ursula Schröder
  • Hans Eckel
  • Markus Hess
  • Michael Schröder
  • Petra Schneider
  • Bünzel Jens
  • Hans P. Zenner
  • Jochen A. Werner
  • Rita Engenhardt-Cabillic
  • Bernhard Vanselow
  • Peter Plinkert
  • Marcus Niewald
  • Thomas Kuhnt
  • Wilfried Budach
  • Michael Flentje
Head and Neck

Abstract

A prospective multicenter phase-II trial (12 centers) was performed by the German larynx organ preservation group (DeLOS) to evaluate the effect of induction chemotherapy (ICHT) with paclitaxel/cisplatin (TP), followed by accelerated-hyperfractionated (concomitant boost) radiotherapy (RT) in responders. The trial was focused on larynx preservation, tumor control, survival, salvage surgery and late toxicity in patients with advanced larynx/hypopharynx carcinoma eligible for total laryngectomy (LE). Seventy-one patients (40 larynx, 87.5% St. III, IV; 31 hypopharynx, 93.4% St. III, IV) were enrolled into the study and treated with ICHT (200 mg/m2 paclitaxel, 100 mg/m2 cisplatin; day 1, 22) according to the DeLOS protocol. Patients with complete or partial tumor response proceeded to RT (69.9 Gy in 5.5 weeks). Non-responders received a LE followed by postoperative RT (56–70 Gy in 5.5–7 weeks). The response rate to ICHT for larynx cancer was 69.6% (7.1% complete, 62.5% partial response) and for hypopharyngeal cancer was 84.3% (6.9% complete, 77.4% partial response). Overall survival after 36 months was 60.3% (95% CI, 48.4–72.2%), after 42 months was 56.5% (95% CI, 44.2–68.8%). Laryngectomy-free survival was as follows: after 36 months, 43.0% (95% CI, 30.9–55.0%); after 42 months, 41.3% (95% CI, 29.3–53.3%). Both parameters did not show different outcomes after distinguishing larynx from hypopharynx. LE was indicated in 15 non-responders after ICHT. Five of the 15 non-responders refused the laryngectomy. Two of the five received RT instead and had no evidence of disease 42 months after RT. Late toxicity (dysphagia III, IV LENT SOMA score in laryngectomy-free survivors: after 6 months, 1.8%; 12 months, 11.4%; 18 months, 14.5%; 24 months, 8.1%; 36 months, 16%) and salvage surgery (4 pharyngocutaneous fistulas in 27 operations) were tolerable. In a large portion of patients eligible for LE, the larynx could be preserved with satisfying functional outcome. Good responders after ICHT had also a good general outcome with relatively rare severe late toxicities. Due to a slight increase of relevant late dysphagia, functional outcome regarding swallowing and tracheotomy free breathing should be more focused in future larynx organ preservation trials.

Keywords

Induction chemo Larynx Hypopharynx cancer Organ preservation Head and neck 

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Copyright information

© Springer-Verlag 2008

Authors and Affiliations

  • Andreas Dietz
    • 1
    • 21
  • Volker Rudat
    • 2
  • Jens Dreyhaupt
    • 3
  • Maria Pritsch
    • 3
  • Florian Hoppe
    • 4
  • Rudolph Hagen
    • 5
  • Leo Pfreundner
    • 6
  • Ursula Schröder
    • 7
  • Hans Eckel
    • 8
  • Markus Hess
    • 9
  • Michael Schröder
    • 10
  • Petra Schneider
    • 11
  • Bünzel Jens
    • 12
  • Hans P. Zenner
    • 13
  • Jochen A. Werner
    • 14
  • Rita Engenhardt-Cabillic
    • 15
  • Bernhard Vanselow
    • 16
  • Peter Plinkert
    • 17
  • Marcus Niewald
    • 18
  • Thomas Kuhnt
    • 19
  • Wilfried Budach
    • 20
  • Michael Flentje
    • 6
  1. 1.Department of Otolaryngology, Head and Neck SurgeryUniversity of LeipzigLeipzigGermany
  2. 2.Saad Specialist HospitalAl KhobarKingdom of Saudi Arabia
  3. 3.Institute for Medical Biometry and InformaticsUniversity of HeidelbergHeidelbergGermany
  4. 4.Department of Otolaryngology, Head and Neck SurgeryCity Hospital OldenburgOldenburgGermany
  5. 5.Department of Otolaryngology, Head and Neck SurgeryUniversity of WürzburgWürzburgGermany
  6. 6.Department of Radiation OncologyUniversity of WürzburgWürzburgGermany
  7. 7.Department of Otolaryngology, Head and Neck SurgeryUniversity of LübeckLübeckGermany
  8. 8.Department of Otolaryngology, Head and Neck SurgeryHospital KlagenfurtKlagenfurtAustria
  9. 9.Department of Otolaryngology, Head and Neck SurgeryUniversity of HamburgHamburgGermany
  10. 10.Department of Otolaryngology, Head and Neck SurgeryCity Hospital KasselKasselGermany
  11. 11.Department of Radiation OncologyCity Hospital KasselKasselGermany
  12. 12.Department of Otolaryngology, Head and Neck SurgeryCity Hospital NordhausenNordhausenGermany
  13. 13.Department of Otolaryngology, Head and Neck SurgeryUniversity of TübingenTübingenGermany
  14. 14.Department of Otolaryngology, Head and Neck SurgeryUniversity of MarburgMarburgGermany
  15. 15.Department of Radiation OncologyUniversity of MarburgMarburgGermany
  16. 16.Department of Otolaryngology, Head and Neck SurgerySt.VincentiusKarlsruheGermany
  17. 17.Department of Otolaryngology, Head and Neck SurgeryUniversity of HeidelbergHeidelbergGermany
  18. 18.Department of Radiation OncologyUniversity of Homburg/SaarlandHomburg/SaarlandGermany
  19. 19.Department of Radiation OncologyUniversity of HalleHalleGermany
  20. 20.Department of Radiation OncologyUniversity of DüsseldorfDüsseldorfGermany
  21. 21.Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde/Plastische OperationenUniversität LeipzigLeipzigGermany

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