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Treatment

SECOND LINE CHEMOTHERAPY WITH METHOTREXATE AND GEMCITABINE IN PATIENTS WITH RELAPSING HEAD AND NECK CANCER (HNC). Emanuel Xydakis, Maria Papadakou, Evangelos Repassos, Maria Poulou, Charalambos Boukis, Gerasimos Panagos Department of Medical Oncology Agii Anargiri Cancer Hospital

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Treatment

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  1. SECOND LINE CHEMOTHERAPY WITH METHOTREXATE AND GEMCITABINE IN PATIENTS WITH RELAPSING HEAD AND NECK CANCER (HNC) Emanuel Xydakis, Maria Papadakou, Evangelos Repassos, Maria Poulou, Charalambos Boukis, Gerasimos Panagos Department of Medical Oncology Agii Anargiri Cancer Hospital Kifisia, Athens, Greece

  2. Patients withhead and neck cancer usually present with locally advanced disease and, despite of aggressive multi-modality treatment, they usually develop loco-regional recurrence or distant metastases • Therapeutic approaches of patients with recurrent and/or metastatic disease are limited. • Most effective agents are methotrexate, cisplatin, carboplatin, bleomycin and 5-FU, with response rates 15-31%

  3. Cisplatin-containing combination chemotherapy improves response rate but affects only slightly long-term survival, since responses are as a rule partial and of a brief duration • There is significant need for developing effective second-line chemotherapy aiming both to symptomatic relief and prolongation of survival in patients resistant to or relapsing after first-line chemotherapy • So far data on the effectiveness of second line chemotherapy are limited

  4. Treatment • Methotrexate 30mg/m2 i.v. bolus and gemcitabine 800mg/m2 as a 30 min infusion on days 1, 8, and 15 • Patients were planned to receive 6 cycles of treatment • In the presence of objective response after 6 cycles, therapy continued for another 3 cycles • In the presence of stable disease 3 more cycles were given if there was any CBR (Clinical Benefit Response) while in the absence of CBR treatment discontinued • Treatment discontinued in any case of disease progression

  5. Patient characteristics

  6. Results-1 • Six patients received only one cycle • Another one received 2cycles and discontinued treatment because of PD • Six of them died of PD at 1 to 3 months from enrolling while the seventh never returned for follow up

  7. Results-2 • Among the 14 adequately treated and evaluable for response patients there were 1 withCR and 2with PR (response rate 21,4%) • The patient with CR remains relapse-free for 74 months until today • The two partial responders relapsed after 14 and 25 months and are still alive at 18 and 32 months • Nine patients developed minor response or stable disease along with symptomatic relief (64,3%) • Overall, 85,7% of patients attained CR, PR, MR, or SD along with CBR

  8. Results-3 • Mean TTP of evaluable patients was 13 months (median 9, range 1 to 74+) • Mean OS of evaluable patients was 20 months (median 13, range 6 to 74+) • Mean TTP of all enrolling patients was 9 months (median 5, range 1 to 74+) • Mean OS of all enrolling patients was 14 months (median 11, range 1 to 74+)

  9. Toxicity • Chemotherapy-related adverse events were generally mild or moderate and easy manageable • Most common side effect was myelotoxicity • Two patients developed grade 2 anaemia and required blood transfusions • Three patients developed grade 1 anaemia and two grade 1 neutropenia • Non-hematological side effects, such as nausea, anorexia, stomatitis, diarrhea, and fever were mild and uncommon

  10. Conclusions • Although both drugs are used extensively in different combinations for a variety of neoplastic diseases, there are no data on the efficacy of them used in combination in treating HNC • Our results are encouraging as the combination has mild to moderate easily managed toxicity, response rate of 21,4%, and 85,7% overall clinical benefit response • TTP and OS of our patients are considerably high in comparison to literature data, and our high values are due to the exceptional response duration of the patient with CR

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