Phase II multicenter study of induction chemotherapy followed by concurrent efaproxiral (RSR13) and thoracic radiotherapy for patients with locally advanced non-small-cell lung cancer

Hak Choy, Abdenour Nabid, Baldassarre Stea, Charles Scott, Wilson Roa, Lawrence R Kleinberg, Joseph Ayoub, Colum Smith, Luis Souhami, Solomon Hamburg, William Spanos, Harvey Kreisman, Adam P. Boyd, Pablo J. Cagnoni, Walter J. Curran

Research output: Contribution to journalArticle

Abstract

Purpose: Efaproxiral (RSR13) reduces hemoglobin oxygen-binding affinity, facilitates oxygen release, and increases tissue pO2. We conducted a phase II multicenter study that assessed the efficacy and safety of efaproxiral when administered with thoracic radiation therapy (TRT), following induction chemotherapy, for treatment of locally advanced non-small-cell lung cancer (NSCLC). Patients and Methods: Fifty-one patients with locally advanced NSCLC were enrolled at 13 sites. Treatment comprised two cycles of paclitaxel (225 mg/m2) and carboplatin (area under the curve, 6), 3 weeks apart, followed by TRT (64 Gy/32 fractions) with concurrent efaproxiral (50 to 100 mg/kg). Survival results were compared with results of study Radiation Therapy Oncology Group (RTOG) 94-10. Results: Overall response rate was 75% (37 of 49 patients). Complete and partial response rates were 6% (three of 49 patients) and 69% (34 of 49 patients), respectively. Median survival time (MST) was 20.6 months (95% CI, 14.0 to 24.2); overall survival rates at 1- and 2-years were 67% and 37%, respectively. Survival results were compared with the sequential (S-CRT) and concurrent (C-CRT) chemoradiotherapy arms of RTOG 94-10. MSTs for cases matched by stage, Karnofsky performance status, and age were: RT-010, 20.6 months; S-CRT, 15.1 months; and C-CRT, 17.9 months. Grade 3 to 4 toxicities related to efaproxiral that occurred in more than one patient included transient hypoxemia (19%), radiation pneumonitis (11%), and fatigue (4%). Conclusion: Addition of efaproxiral to SCRT represents a promising approach in NSCLC treatment, and a randomized study should be pursued. The low incidence of grade 3 to 4 toxicities suggests that the use of efaproxiral instead of a cytotoxic agent, as a radiation sensitizer, may be advantageous.

Original languageEnglish (US)
Pages (from-to)5918-5928
Number of pages11
JournalJournal of Clinical Oncology
Volume23
Issue number25
DOIs
StatePublished - 2005

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Induction Chemotherapy
Non-Small Cell Lung Carcinoma
Multicenter Studies
Radiotherapy
Thorax
Radiation Oncology
Survival
Radiation Pneumonitis
Radiation-Sensitizing Agents
Oxygen
Karnofsky Performance Status
Carboplatin
Cytotoxins
Chemoradiotherapy
Paclitaxel
efaproxiral
Area Under Curve
Fatigue
Hemoglobins
Therapeutics

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Phase II multicenter study of induction chemotherapy followed by concurrent efaproxiral (RSR13) and thoracic radiotherapy for patients with locally advanced non-small-cell lung cancer. / Choy, Hak; Nabid, Abdenour; Stea, Baldassarre; Scott, Charles; Roa, Wilson; Kleinberg, Lawrence R; Ayoub, Joseph; Smith, Colum; Souhami, Luis; Hamburg, Solomon; Spanos, William; Kreisman, Harvey; Boyd, Adam P.; Cagnoni, Pablo J.; Curran, Walter J.

In: Journal of Clinical Oncology, Vol. 23, No. 25, 2005, p. 5918-5928.

Research output: Contribution to journalArticle

Choy, H, Nabid, A, Stea, B, Scott, C, Roa, W, Kleinberg, LR, Ayoub, J, Smith, C, Souhami, L, Hamburg, S, Spanos, W, Kreisman, H, Boyd, AP, Cagnoni, PJ & Curran, WJ 2005, 'Phase II multicenter study of induction chemotherapy followed by concurrent efaproxiral (RSR13) and thoracic radiotherapy for patients with locally advanced non-small-cell lung cancer', Journal of Clinical Oncology, vol. 23, no. 25, pp. 5918-5928. https://doi.org/10.1200/JCO.2005.08.011
Choy, Hak ; Nabid, Abdenour ; Stea, Baldassarre ; Scott, Charles ; Roa, Wilson ; Kleinberg, Lawrence R ; Ayoub, Joseph ; Smith, Colum ; Souhami, Luis ; Hamburg, Solomon ; Spanos, William ; Kreisman, Harvey ; Boyd, Adam P. ; Cagnoni, Pablo J. ; Curran, Walter J. / Phase II multicenter study of induction chemotherapy followed by concurrent efaproxiral (RSR13) and thoracic radiotherapy for patients with locally advanced non-small-cell lung cancer. In: Journal of Clinical Oncology. 2005 ; Vol. 23, No. 25. pp. 5918-5928.
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title = "Phase II multicenter study of induction chemotherapy followed by concurrent efaproxiral (RSR13) and thoracic radiotherapy for patients with locally advanced non-small-cell lung cancer",
abstract = "Purpose: Efaproxiral (RSR13) reduces hemoglobin oxygen-binding affinity, facilitates oxygen release, and increases tissue pO2. We conducted a phase II multicenter study that assessed the efficacy and safety of efaproxiral when administered with thoracic radiation therapy (TRT), following induction chemotherapy, for treatment of locally advanced non-small-cell lung cancer (NSCLC). Patients and Methods: Fifty-one patients with locally advanced NSCLC were enrolled at 13 sites. Treatment comprised two cycles of paclitaxel (225 mg/m2) and carboplatin (area under the curve, 6), 3 weeks apart, followed by TRT (64 Gy/32 fractions) with concurrent efaproxiral (50 to 100 mg/kg). Survival results were compared with results of study Radiation Therapy Oncology Group (RTOG) 94-10. Results: Overall response rate was 75{\%} (37 of 49 patients). Complete and partial response rates were 6{\%} (three of 49 patients) and 69{\%} (34 of 49 patients), respectively. Median survival time (MST) was 20.6 months (95{\%} CI, 14.0 to 24.2); overall survival rates at 1- and 2-years were 67{\%} and 37{\%}, respectively. Survival results were compared with the sequential (S-CRT) and concurrent (C-CRT) chemoradiotherapy arms of RTOG 94-10. MSTs for cases matched by stage, Karnofsky performance status, and age were: RT-010, 20.6 months; S-CRT, 15.1 months; and C-CRT, 17.9 months. Grade 3 to 4 toxicities related to efaproxiral that occurred in more than one patient included transient hypoxemia (19{\%}), radiation pneumonitis (11{\%}), and fatigue (4{\%}). Conclusion: Addition of efaproxiral to SCRT represents a promising approach in NSCLC treatment, and a randomized study should be pursued. The low incidence of grade 3 to 4 toxicities suggests that the use of efaproxiral instead of a cytotoxic agent, as a radiation sensitizer, may be advantageous.",
author = "Hak Choy and Abdenour Nabid and Baldassarre Stea and Charles Scott and Wilson Roa and Kleinberg, {Lawrence R} and Joseph Ayoub and Colum Smith and Luis Souhami and Solomon Hamburg and William Spanos and Harvey Kreisman and Boyd, {Adam P.} and Cagnoni, {Pablo J.} and Curran, {Walter J.}",
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T1 - Phase II multicenter study of induction chemotherapy followed by concurrent efaproxiral (RSR13) and thoracic radiotherapy for patients with locally advanced non-small-cell lung cancer

AU - Choy, Hak

AU - Nabid, Abdenour

AU - Stea, Baldassarre

AU - Scott, Charles

AU - Roa, Wilson

AU - Kleinberg, Lawrence R

AU - Ayoub, Joseph

AU - Smith, Colum

AU - Souhami, Luis

AU - Hamburg, Solomon

AU - Spanos, William

AU - Kreisman, Harvey

AU - Boyd, Adam P.

AU - Cagnoni, Pablo J.

AU - Curran, Walter J.

PY - 2005

Y1 - 2005

N2 - Purpose: Efaproxiral (RSR13) reduces hemoglobin oxygen-binding affinity, facilitates oxygen release, and increases tissue pO2. We conducted a phase II multicenter study that assessed the efficacy and safety of efaproxiral when administered with thoracic radiation therapy (TRT), following induction chemotherapy, for treatment of locally advanced non-small-cell lung cancer (NSCLC). Patients and Methods: Fifty-one patients with locally advanced NSCLC were enrolled at 13 sites. Treatment comprised two cycles of paclitaxel (225 mg/m2) and carboplatin (area under the curve, 6), 3 weeks apart, followed by TRT (64 Gy/32 fractions) with concurrent efaproxiral (50 to 100 mg/kg). Survival results were compared with results of study Radiation Therapy Oncology Group (RTOG) 94-10. Results: Overall response rate was 75% (37 of 49 patients). Complete and partial response rates were 6% (three of 49 patients) and 69% (34 of 49 patients), respectively. Median survival time (MST) was 20.6 months (95% CI, 14.0 to 24.2); overall survival rates at 1- and 2-years were 67% and 37%, respectively. Survival results were compared with the sequential (S-CRT) and concurrent (C-CRT) chemoradiotherapy arms of RTOG 94-10. MSTs for cases matched by stage, Karnofsky performance status, and age were: RT-010, 20.6 months; S-CRT, 15.1 months; and C-CRT, 17.9 months. Grade 3 to 4 toxicities related to efaproxiral that occurred in more than one patient included transient hypoxemia (19%), radiation pneumonitis (11%), and fatigue (4%). Conclusion: Addition of efaproxiral to SCRT represents a promising approach in NSCLC treatment, and a randomized study should be pursued. The low incidence of grade 3 to 4 toxicities suggests that the use of efaproxiral instead of a cytotoxic agent, as a radiation sensitizer, may be advantageous.

AB - Purpose: Efaproxiral (RSR13) reduces hemoglobin oxygen-binding affinity, facilitates oxygen release, and increases tissue pO2. We conducted a phase II multicenter study that assessed the efficacy and safety of efaproxiral when administered with thoracic radiation therapy (TRT), following induction chemotherapy, for treatment of locally advanced non-small-cell lung cancer (NSCLC). Patients and Methods: Fifty-one patients with locally advanced NSCLC were enrolled at 13 sites. Treatment comprised two cycles of paclitaxel (225 mg/m2) and carboplatin (area under the curve, 6), 3 weeks apart, followed by TRT (64 Gy/32 fractions) with concurrent efaproxiral (50 to 100 mg/kg). Survival results were compared with results of study Radiation Therapy Oncology Group (RTOG) 94-10. Results: Overall response rate was 75% (37 of 49 patients). Complete and partial response rates were 6% (three of 49 patients) and 69% (34 of 49 patients), respectively. Median survival time (MST) was 20.6 months (95% CI, 14.0 to 24.2); overall survival rates at 1- and 2-years were 67% and 37%, respectively. Survival results were compared with the sequential (S-CRT) and concurrent (C-CRT) chemoradiotherapy arms of RTOG 94-10. MSTs for cases matched by stage, Karnofsky performance status, and age were: RT-010, 20.6 months; S-CRT, 15.1 months; and C-CRT, 17.9 months. Grade 3 to 4 toxicities related to efaproxiral that occurred in more than one patient included transient hypoxemia (19%), radiation pneumonitis (11%), and fatigue (4%). Conclusion: Addition of efaproxiral to SCRT represents a promising approach in NSCLC treatment, and a randomized study should be pursued. The low incidence of grade 3 to 4 toxicities suggests that the use of efaproxiral instead of a cytotoxic agent, as a radiation sensitizer, may be advantageous.

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