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P72 Comorbidity and survival in elderly with locoregionally advanced squamocellular head and neck carcinomas (LA SCCHN)
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Critical Reviews in Oncology/Hematology 72S1 (2009)
Gefitinib given at 250 mg at bedtime, 5 days a week. Paclitaxel + Carboplat given in the dose 80 mg/m2 and Carbo AUC 2 in 3 out of 4 weeks. All patients who received 2 cycles evaluated for toxicity and tolerance. All patients completing 4 cycle evaluated for efficacy. Result(s): 141 patients randomized after consent. 128 completed 2 cycles of treatment i.e. 8 weeks of treatment. 118 completed beyond 4 cycles i.e. 16 weeks of treatment. (Percentages in whole numbers for convenience) 50% patients – PS = 1, 32% patients – PS = 2, 18% patients – PS = 0. Response to only Gefitinib = 21%, response to weekly Paclitaxel + Carboplat = 22%, response to Intermittent Gefitinib with weekly Paclitaxel + Carboplat = 51%. Toxicity, neuropathy in Paclitaxel + Carboplat as well as Gefitinib with Paclitaxel + Carbopalt. Neuropathy Grade 3 / 4 – 12% and 14% respectively. Neutropenia Grade 3 / 4 in 8% and 12% respectively. Rash seen in 30% of all patients receiving Gefitinib. Median time to progression in only Gefitinib – 11 months, weekly Paclitaxel + Carboplat – 13 months, and Intermittent Gefitinib and Paclitaxel + Carboplat – 17 months. Conclusion(s): Intermittent Gefitinib and Paclitaxel + Carboplat is well tolerated and efficacious. Larger studies are warranted to prove this.
Head & Neck P71 Tamoxifen–Norfloxacin interaction induced Q-T interval prolongation in an older female patient with extracranial meningioma: a case report L. Slovacek1,2 , P. Priester1 *, I. Slanska1 , J. Petera1 . 1 Charles University Hospital and Faculty of Medicine, Department of Clinical Oncology and Radiation Therapy, Hradec Kralove, Czech Republic, 2 Faculty of Military Health Sciences, Department of Field Internal Medicine, Hradec Kralove, Czech Republic Purpose of the study: Tamoxifen is an orally active selective estrogen receptor modulator (SERM) that is used in the treatment of breast cancer and is currently the world’s largest selling drug for that purpose. Tamoxifen is currently used for the treatment of both early and advanced ER+ (estrogen receptor positive) breast cancer in pre- and post-menopausal women. Methods: The authors report on a case of tamoxifen-induced QT interval prolongation in a 83 year-old female patient with extracranial meningioma treated with radiation and hormonal therapy. Results: This case highlights the risk of tamoxifen causing depression of electrical impulse in the sino-atrial node, leading to symptomatic sinus bradycardia with prolonged QT interval. It indicates the necessity of regular monitoring of patients undergoing tamoxifen treatment. Electrocardiogram (ECG) should be performed not only before and after, but also during treatment. With an average duration of treatment of 5 years, the authors would advise an annual ECG for asymptomatic patients. In the presence of symptomatic sinus bradycardia, constant monitoring is necessary. The authors also highlight potential drug interactions, between tamoxifen and norfloxacin and the need to be aware of drugs which may induce QT interval prolongation. Conclusions: A case report highlights: 1. The potential risk of tamoxifen causing depression of electrical impulse in sinoatrial node, leading to symptomatic sinus bradycardia with prolonged QT interval. 2. The need to monitor patients undergoing tamoxifen treatment regulary. ECG should be performed not only before and after, but also during treatment. With an average duration of treatment of 5 years, we would advise an annual ECG. In the presence of symptomatic sinus bradycardia, constant monitoring is necessary. 3. The need to keep a look-out for drug interactions, in our case between tamoxifen and norfloxacin, and to be aware of other drugs which may induce QT interval prolongation. Supported by the Research Project of the Ministry of Defense of the Czech Republic No. 0FVZ0000503 and the Research Project of the Ministry of Health of the Czech Republic No. 00179906.
10th SIOG Meeting, October 15–17, 2009, Berlin, Germany P72 Comorbidity and survival in elderly with locoregionally advanced squamocellular head and neck carcinomas (LA SCCHN) M. Kreacic *, S. Jelic, T. Ursulovic, J. Jovanovic, N. Medic-Milijic. Institute for Oncology and Radiology of Serbia, Belgrade, Serbia Purpose of the study: To assess the impact of comorbidity on survival in subgroup of elderly patients with LA SCCHN. Method(s): To improve activity of standard Platinum-Fluorouracil (PF) regimen, we added to it Cytarabine (CAR) as a Platinum potentiator in a neoadjuvant setting. During two-year period, we treated this way a total of 105 patients (N = 105) with stage IVB disease (AJCC, 2002). Among them 14 elderlies (13%) were identified. All were males, median age being 67 yrs (range 65−72 yrs), heavy smokers and drinkers. Their performance status was ECOG 1 (range 0−2). They received CPF regimen with 500 mg/m2 of CAR (D1), 750 mg/m2 of 5FU as a continuous infsusion (D1-D5) and CDDP 120 mg/m2 (D1). After 6 cycles all were evaluated and depending of response proceeded to definitive radiotherapy. Because of relative data paucity regarding the impact of comorbidity on survival in this population, we used the Adult comorbidity evaluation index (ACE-27) as an assessment tool. Result(s): Response rate was 36% and disease control rate (CR+PR+SD) was 71%. Five pts were without comorbidity (score 0), 5 pts had score 1 (mild), 3 pts score 2 (moderate) and one had score 3 (severe). Median follow-up was 15 months (range 3−50 months), median survival being 15 months too. The most prevalent comorbid condition were alcohol abuse and mild hypertension. We did not find significant statistical difference in overall survival between pts without comorbidities (score 0), and all other pts (1+2+3)- log rank, p = 0.104. Conclusion(s): The possible explanation of our results might be the small sample of patients which interferes with correct conslusions. So larger studies properly designed for elderlies with LA SCCHN are of paramount importance, for proper staging and treatment planning. P73 Oral cavity squamous cell carcinoma in 260 patients aged 80 years or more C. Ortholan1 *, A. Lusinchi2 , A. Italiano3 , R.-J. Bensadoun1 , A. Auperin4 , O. Dassonville5 , G. Poissonnet5 , A. Bozec5 , R. Arriagada2 , S. Temam6 , K. Benezery1 , J. Thariat1 , J. Bourhis2 . 1 Department of Radiotherapy, Centre Antoine-Lacassagne, Nice, France, 2 Department of Radiotherapy, Institut de Canc´erologie Gustave Roussy, Villejuif, France, 3 Department of Medical Oncology, Centre Antoine-Lacassagne, Nice, France, 4 Department of Biostatistics and Epidemiology, Institut de Canc´ erologie Gustave Roussy, Villejuif, France, 5 Department of Head and Neck Surgery, Centre Antoine-Lacassagne, Nice, France, 6 Department of Head and Neck Surgery, Institut de Canc´erologie Gustave Roussy, Villejuif, France, 7 Department of Pathology, Centre Antoine-Lacassagne, Nice, France Purpose of the study: We report here the experience of two French cancer centers in the treatment of oral cavity SCC in patients aged 80 years. Method(s): All the patients aged 80 years with primary oral cavity SCC referred to the Antoine-Lacassagne Cancer Center (Nice, France) and to the Gustave Roussy Cancer Institute (Villejuif, France) from 1987 to 2007 were included in this retrospective study. In patients treated with a curative intent, an “adapted to age” treatment was defined as one or more of the following planned adaptations: resectable tumor denied for surgery being replaced by definitive radiotherapy, no adjuvant radiotherapy after surgery when required, no neck node dissection/irradiation when required, unconventional fractionation or total planned dose for radiotherapy. Result(s): The study population included 260 patients. The median followup was 102.6 months (Schemper method). Sex ratio was near to 1. Tobacco or alcohol intoxication was the main risk factor for 66% of men and 16% of women and leukoplakia/lichen planus/oral traumatism for 55% of women and 11% of men (p < 0.0001). 200 patients (77%) received a loco regional treatment in a curative intent and 29 (11%) in a palliative intent. Curative treatments were initially planned to be “adapted to age” in 118 patients (59%). Surgery was indicated in 152 patients, but it was replaced by definitive radiotherapy
Critical Reviews in Oncology/Hematology 72S1 (2009)
Gefitinib given at 250 mg at bedtime, 5 days a week. Paclitaxel + Carboplat given in the dose 80 mg/m2 and Carbo AUC 2 in 3 out of 4 weeks. All patients who received 2 cycles evaluated for toxicity and tolerance. All patients completing 4 cycle evaluated for efficacy. Result(s): 141 patients randomized after consent. 128 completed 2 cycles of treatment i.e. 8 weeks of treatment. 118 completed beyond 4 cycles i.e. 16 weeks of treatment. (Percentages in whole numbers for convenience) 50% patients – PS = 1, 32% patients – PS = 2, 18% patients – PS = 0. Response to only Gefitinib = 21%, response to weekly Paclitaxel + Carboplat = 22%, response to Intermittent Gefitinib with weekly Paclitaxel + Carboplat = 51%. Toxicity, neuropathy in Paclitaxel + Carboplat as well as Gefitinib with Paclitaxel + Carbopalt. Neuropathy Grade 3 / 4 – 12% and 14% respectively. Neutropenia Grade 3 / 4 in 8% and 12% respectively. Rash seen in 30% of all patients receiving Gefitinib. Median time to progression in only Gefitinib – 11 months, weekly Paclitaxel + Carboplat – 13 months, and Intermittent Gefitinib and Paclitaxel + Carboplat – 17 months. Conclusion(s): Intermittent Gefitinib and Paclitaxel + Carboplat is well tolerated and efficacious. Larger studies are warranted to prove this.
Head & Neck P71 Tamoxifen–Norfloxacin interaction induced Q-T interval prolongation in an older female patient with extracranial meningioma: a case report L. Slovacek1,2 , P. Priester1 *, I. Slanska1 , J. Petera1 . 1 Charles University Hospital and Faculty of Medicine, Department of Clinical Oncology and Radiation Therapy, Hradec Kralove, Czech Republic, 2 Faculty of Military Health Sciences, Department of Field Internal Medicine, Hradec Kralove, Czech Republic Purpose of the study: Tamoxifen is an orally active selective estrogen receptor modulator (SERM) that is used in the treatment of breast cancer and is currently the world’s largest selling drug for that purpose. Tamoxifen is currently used for the treatment of both early and advanced ER+ (estrogen receptor positive) breast cancer in pre- and post-menopausal women. Methods: The authors report on a case of tamoxifen-induced QT interval prolongation in a 83 year-old female patient with extracranial meningioma treated with radiation and hormonal therapy. Results: This case highlights the risk of tamoxifen causing depression of electrical impulse in the sino-atrial node, leading to symptomatic sinus bradycardia with prolonged QT interval. It indicates the necessity of regular monitoring of patients undergoing tamoxifen treatment. Electrocardiogram (ECG) should be performed not only before and after, but also during treatment. With an average duration of treatment of 5 years, the authors would advise an annual ECG for asymptomatic patients. In the presence of symptomatic sinus bradycardia, constant monitoring is necessary. The authors also highlight potential drug interactions, between tamoxifen and norfloxacin and the need to be aware of drugs which may induce QT interval prolongation. Conclusions: A case report highlights: 1. The potential risk of tamoxifen causing depression of electrical impulse in sinoatrial node, leading to symptomatic sinus bradycardia with prolonged QT interval. 2. The need to monitor patients undergoing tamoxifen treatment regulary. ECG should be performed not only before and after, but also during treatment. With an average duration of treatment of 5 years, we would advise an annual ECG. In the presence of symptomatic sinus bradycardia, constant monitoring is necessary. 3. The need to keep a look-out for drug interactions, in our case between tamoxifen and norfloxacin, and to be aware of other drugs which may induce QT interval prolongation. Supported by the Research Project of the Ministry of Defense of the Czech Republic No. 0FVZ0000503 and the Research Project of the Ministry of Health of the Czech Republic No. 00179906.
10th SIOG Meeting, October 15–17, 2009, Berlin, Germany P72 Comorbidity and survival in elderly with locoregionally advanced squamocellular head and neck carcinomas (LA SCCHN) M. Kreacic *, S. Jelic, T. Ursulovic, J. Jovanovic, N. Medic-Milijic. Institute for Oncology and Radiology of Serbia, Belgrade, Serbia Purpose of the study: To assess the impact of comorbidity on survival in subgroup of elderly patients with LA SCCHN. Method(s): To improve activity of standard Platinum-Fluorouracil (PF) regimen, we added to it Cytarabine (CAR) as a Platinum potentiator in a neoadjuvant setting. During two-year period, we treated this way a total of 105 patients (N = 105) with stage IVB disease (AJCC, 2002). Among them 14 elderlies (13%) were identified. All were males, median age being 67 yrs (range 65−72 yrs), heavy smokers and drinkers. Their performance status was ECOG 1 (range 0−2). They received CPF regimen with 500 mg/m2 of CAR (D1), 750 mg/m2 of 5FU as a continuous infsusion (D1-D5) and CDDP 120 mg/m2 (D1). After 6 cycles all were evaluated and depending of response proceeded to definitive radiotherapy. Because of relative data paucity regarding the impact of comorbidity on survival in this population, we used the Adult comorbidity evaluation index (ACE-27) as an assessment tool. Result(s): Response rate was 36% and disease control rate (CR+PR+SD) was 71%. Five pts were without comorbidity (score 0), 5 pts had score 1 (mild), 3 pts score 2 (moderate) and one had score 3 (severe). Median follow-up was 15 months (range 3−50 months), median survival being 15 months too. The most prevalent comorbid condition were alcohol abuse and mild hypertension. We did not find significant statistical difference in overall survival between pts without comorbidities (score 0), and all other pts (1+2+3)- log rank, p = 0.104. Conclusion(s): The possible explanation of our results might be the small sample of patients which interferes with correct conslusions. So larger studies properly designed for elderlies with LA SCCHN are of paramount importance, for proper staging and treatment planning. P73 Oral cavity squamous cell carcinoma in 260 patients aged 80 years or more C. Ortholan1 *, A. Lusinchi2 , A. Italiano3 , R.-J. Bensadoun1 , A. Auperin4 , O. Dassonville5 , G. Poissonnet5 , A. Bozec5 , R. Arriagada2 , S. Temam6 , K. Benezery1 , J. Thariat1 , J. Bourhis2 . 1 Department of Radiotherapy, Centre Antoine-Lacassagne, Nice, France, 2 Department of Radiotherapy, Institut de Canc´erologie Gustave Roussy, Villejuif, France, 3 Department of Medical Oncology, Centre Antoine-Lacassagne, Nice, France, 4 Department of Biostatistics and Epidemiology, Institut de Canc´ erologie Gustave Roussy, Villejuif, France, 5 Department of Head and Neck Surgery, Centre Antoine-Lacassagne, Nice, France, 6 Department of Head and Neck Surgery, Institut de Canc´erologie Gustave Roussy, Villejuif, France, 7 Department of Pathology, Centre Antoine-Lacassagne, Nice, France Purpose of the study: We report here the experience of two French cancer centers in the treatment of oral cavity SCC in patients aged 80 years. Method(s): All the patients aged 80 years with primary oral cavity SCC referred to the Antoine-Lacassagne Cancer Center (Nice, France) and to the Gustave Roussy Cancer Institute (Villejuif, France) from 1987 to 2007 were included in this retrospective study. In patients treated with a curative intent, an “adapted to age” treatment was defined as one or more of the following planned adaptations: resectable tumor denied for surgery being replaced by definitive radiotherapy, no adjuvant radiotherapy after surgery when required, no neck node dissection/irradiation when required, unconventional fractionation or total planned dose for radiotherapy. Result(s): The study population included 260 patients. The median followup was 102.6 months (Schemper method). Sex ratio was near to 1. Tobacco or alcohol intoxication was the main risk factor for 66% of men and 16% of women and leukoplakia/lichen planus/oral traumatism for 55% of women and 11% of men (p < 0.0001). 200 patients (77%) received a loco regional treatment in a curative intent and 29 (11%) in a palliative intent. Curative treatments were initially planned to be “adapted to age” in 118 patients (59%). Surgery was indicated in 152 patients, but it was replaced by definitive radiotherapy