Intraarterial Cisplatin with Intravenous Paclitaxel and Ifosfamide as an Organ-Preservation Approach in Patients with Paranasal Sinus Carcinoma

Vassiliki A Papadimitrakopoulou, Lawrence E Ginsberg, Adam S Garden, Merrill S Kies, Bonnie S Glisson, Eduardo M Diaz Jr, Gary Clayman, William H Morrison, Diane D. Liu, George R Blumenschein, Scott M. Lippman, Donald Schommer, Ann Marie Gillenwater, Helmuth Goepfert, Waun K. Hong

Research output: Contribution to journalArticle

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Abstract

BACKGROUND. The objectives of this study were to determine the efficacy, organ-preservation rate, and safety of intraarterial (IA) cisplatin in combination with intravenous paclitaxel and ifosfamide in patients with locally advanced carcinoma of the paranasal sinuses who required orbital exenteration or major craniofacial resection for complete tumor resection. METHODS. Patients were treated with intravenous paclitaxel (135 mg/m2) on Day 1, ifosfamide (1000 mg/m2) on Days 1-3, sodium mercaptoethanesulfonate (600 mg/m2) on Days 1-3, and IA cisplatin (100 mg/m2) on Day 1 every 21 days. RESULTS. Of 24 study participants, 20 patients received at least 1 course of IA cisplatin, 1 patient had an early death, and 19 patients were evaluable for response. Five of those 19 patients (26%) achieved a complete response (CR), 6 patients (32%) achieved a partial response, and 8 patients (42%) had stable disease or developed progressive disease. Eye-sparing surgery followed by radiotherapy (RT) was feasible in 7 of 24 patients. RT was offered to only 7 patients, whereas 3 patients received chemotherapy and RT, 2 patients refused further therapy, 3 patients underwent craniofacial resection with orbitectomy, and 1 patient was treated systemically for metastatic disease. At the completion of treatment, 14 of 23 patients (61%) with locally advanced disease were disease free, and the orbit was preserved in 21 of 24 patients (88%). The overall survival, progression-free survival, and disease-free survival rates at 2 years were 60%, 50%, and 84%, respectively. Toxicity was substantial, with two patients experiencing cerebrovascular ischemia (one transient and one cerebrovascular accident) and three patients experiencing cranial neuropathy, which was reversible in two patients. CONCLUSIONS. Despite the encouraging organ-preservation rate, the approach studied resulted in substantial toxicity, and more effective adjunctive therapy is needed. Alternative approaches, including the integration of targeted therapy agents in induction chemotherapy regimens followed by concomitant chemotherapy and RT or eye-sparing surgery, need further exploration.

Original languageEnglish (US)
Pages (from-to)2214-2223
Number of pages10
JournalCancer
Volume98
Issue number10
DOIs
StatePublished - Nov 15 2003

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Organ Preservation
Ifosfamide
Paranasal Sinuses
Paclitaxel
Cisplatin
Carcinoma
Radiotherapy
Disease-Free Survival
Cranial Nerve Diseases
Drug Therapy

Keywords

  • Intraarterial cisplatin
  • Organ preservation
  • Paranasal sinus carcinoma
  • Radiotherapy

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Intraarterial Cisplatin with Intravenous Paclitaxel and Ifosfamide as an Organ-Preservation Approach in Patients with Paranasal Sinus Carcinoma. / Papadimitrakopoulou, Vassiliki A; Ginsberg, Lawrence E; Garden, Adam S; Kies, Merrill S; Glisson, Bonnie S; Diaz Jr, Eduardo M; Clayman, Gary; Morrison, William H; Liu, Diane D.; Blumenschein, George R; Lippman, Scott M.; Schommer, Donald; Gillenwater, Ann Marie; Goepfert, Helmuth; Hong, Waun K.

In: Cancer, Vol. 98, No. 10, 15.11.2003, p. 2214-2223.

Research output: Contribution to journalArticle

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abstract = "BACKGROUND. The objectives of this study were to determine the efficacy, organ-preservation rate, and safety of intraarterial (IA) cisplatin in combination with intravenous paclitaxel and ifosfamide in patients with locally advanced carcinoma of the paranasal sinuses who required orbital exenteration or major craniofacial resection for complete tumor resection. METHODS. Patients were treated with intravenous paclitaxel (135 mg/m2) on Day 1, ifosfamide (1000 mg/m2) on Days 1-3, sodium mercaptoethanesulfonate (600 mg/m2) on Days 1-3, and IA cisplatin (100 mg/m2) on Day 1 every 21 days. RESULTS. Of 24 study participants, 20 patients received at least 1 course of IA cisplatin, 1 patient had an early death, and 19 patients were evaluable for response. Five of those 19 patients (26{\%}) achieved a complete response (CR), 6 patients (32{\%}) achieved a partial response, and 8 patients (42{\%}) had stable disease or developed progressive disease. Eye-sparing surgery followed by radiotherapy (RT) was feasible in 7 of 24 patients. RT was offered to only 7 patients, whereas 3 patients received chemotherapy and RT, 2 patients refused further therapy, 3 patients underwent craniofacial resection with orbitectomy, and 1 patient was treated systemically for metastatic disease. At the completion of treatment, 14 of 23 patients (61{\%}) with locally advanced disease were disease free, and the orbit was preserved in 21 of 24 patients (88{\%}). The overall survival, progression-free survival, and disease-free survival rates at 2 years were 60{\%}, 50{\%}, and 84{\%}, respectively. Toxicity was substantial, with two patients experiencing cerebrovascular ischemia (one transient and one cerebrovascular accident) and three patients experiencing cranial neuropathy, which was reversible in two patients. CONCLUSIONS. Despite the encouraging organ-preservation rate, the approach studied resulted in substantial toxicity, and more effective adjunctive therapy is needed. Alternative approaches, including the integration of targeted therapy agents in induction chemotherapy regimens followed by concomitant chemotherapy and RT or eye-sparing surgery, need further exploration.",
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T1 - Intraarterial Cisplatin with Intravenous Paclitaxel and Ifosfamide as an Organ-Preservation Approach in Patients with Paranasal Sinus Carcinoma

AU - Papadimitrakopoulou, Vassiliki A

AU - Ginsberg, Lawrence E

AU - Garden, Adam S

AU - Kies, Merrill S

AU - Glisson, Bonnie S

AU - Diaz Jr, Eduardo M

AU - Clayman, Gary

AU - Morrison, William H

AU - Liu, Diane D.

AU - Blumenschein, George R

AU - Lippman, Scott M.

AU - Schommer, Donald

AU - Gillenwater, Ann Marie

AU - Goepfert, Helmuth

AU - Hong, Waun K.

PY - 2003/11/15

Y1 - 2003/11/15

N2 - BACKGROUND. The objectives of this study were to determine the efficacy, organ-preservation rate, and safety of intraarterial (IA) cisplatin in combination with intravenous paclitaxel and ifosfamide in patients with locally advanced carcinoma of the paranasal sinuses who required orbital exenteration or major craniofacial resection for complete tumor resection. METHODS. Patients were treated with intravenous paclitaxel (135 mg/m2) on Day 1, ifosfamide (1000 mg/m2) on Days 1-3, sodium mercaptoethanesulfonate (600 mg/m2) on Days 1-3, and IA cisplatin (100 mg/m2) on Day 1 every 21 days. RESULTS. Of 24 study participants, 20 patients received at least 1 course of IA cisplatin, 1 patient had an early death, and 19 patients were evaluable for response. Five of those 19 patients (26%) achieved a complete response (CR), 6 patients (32%) achieved a partial response, and 8 patients (42%) had stable disease or developed progressive disease. Eye-sparing surgery followed by radiotherapy (RT) was feasible in 7 of 24 patients. RT was offered to only 7 patients, whereas 3 patients received chemotherapy and RT, 2 patients refused further therapy, 3 patients underwent craniofacial resection with orbitectomy, and 1 patient was treated systemically for metastatic disease. At the completion of treatment, 14 of 23 patients (61%) with locally advanced disease were disease free, and the orbit was preserved in 21 of 24 patients (88%). The overall survival, progression-free survival, and disease-free survival rates at 2 years were 60%, 50%, and 84%, respectively. Toxicity was substantial, with two patients experiencing cerebrovascular ischemia (one transient and one cerebrovascular accident) and three patients experiencing cranial neuropathy, which was reversible in two patients. CONCLUSIONS. Despite the encouraging organ-preservation rate, the approach studied resulted in substantial toxicity, and more effective adjunctive therapy is needed. Alternative approaches, including the integration of targeted therapy agents in induction chemotherapy regimens followed by concomitant chemotherapy and RT or eye-sparing surgery, need further exploration.

AB - BACKGROUND. The objectives of this study were to determine the efficacy, organ-preservation rate, and safety of intraarterial (IA) cisplatin in combination with intravenous paclitaxel and ifosfamide in patients with locally advanced carcinoma of the paranasal sinuses who required orbital exenteration or major craniofacial resection for complete tumor resection. METHODS. Patients were treated with intravenous paclitaxel (135 mg/m2) on Day 1, ifosfamide (1000 mg/m2) on Days 1-3, sodium mercaptoethanesulfonate (600 mg/m2) on Days 1-3, and IA cisplatin (100 mg/m2) on Day 1 every 21 days. RESULTS. Of 24 study participants, 20 patients received at least 1 course of IA cisplatin, 1 patient had an early death, and 19 patients were evaluable for response. Five of those 19 patients (26%) achieved a complete response (CR), 6 patients (32%) achieved a partial response, and 8 patients (42%) had stable disease or developed progressive disease. Eye-sparing surgery followed by radiotherapy (RT) was feasible in 7 of 24 patients. RT was offered to only 7 patients, whereas 3 patients received chemotherapy and RT, 2 patients refused further therapy, 3 patients underwent craniofacial resection with orbitectomy, and 1 patient was treated systemically for metastatic disease. At the completion of treatment, 14 of 23 patients (61%) with locally advanced disease were disease free, and the orbit was preserved in 21 of 24 patients (88%). The overall survival, progression-free survival, and disease-free survival rates at 2 years were 60%, 50%, and 84%, respectively. Toxicity was substantial, with two patients experiencing cerebrovascular ischemia (one transient and one cerebrovascular accident) and three patients experiencing cranial neuropathy, which was reversible in two patients. CONCLUSIONS. Despite the encouraging organ-preservation rate, the approach studied resulted in substantial toxicity, and more effective adjunctive therapy is needed. Alternative approaches, including the integration of targeted therapy agents in induction chemotherapy regimens followed by concomitant chemotherapy and RT or eye-sparing surgery, need further exploration.

KW - Intraarterial cisplatin

KW - Organ preservation

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KW - Radiotherapy

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