Second line therapy with axitinib after only prior sunitinib in metastatic renal cell cancer: Italian multicenter real world SAX study final results.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Facchini Gaetano, Rossetti Sabrina, Berretta Massimiliano, Cavaliere Carla, Scagliarini Sarah, Vitale Maria Giuseppa, Ciccarese Chiara, Di Lorenzo Giuseppe, Palesandro Erica, Conteduca Vincenza, Basso Umberto, Naglieri Emanuele, Farnesi Azzurra, Aieta Michele, Borsellino Nicolò, La Torre Leonardo, Iovane Gelsomina, Bonomi Lucia, Gasparro Donatello, Ricevuto Enrico, De Tursi Michele, De Vivo Rocco, Lo Re Giovanni, Grillone Francesco, Marchetti Paolo, De Vita Ferdinando, Scavelli Claudio, Sini Claudio, Pisconti Salvatore, Crispo Anna, Gebbia Vittorio, Maestri Antonio, Galli Luca, De Giorgi Ugo, Iacovelli Roberto, Buonerba Carlo, Cartenì Giacomo, D'Aniello Carmine
Аннотация
METHODS: 148 mRCC patients were evaluated. According to Heng score 15.5%, 60.1% and 24.4% of patients were at poor risk, intermediate and favorable risk, respectively.
RESULTS: PFS, OS, DCR and ORR were 7.14 months, 15.5 months, 70.6% and 16.6%, respectively. The duration of prior sunitinib treatment correlated with a longer significant mPFS, 8.8 vs 6.3 months, respectively. Axitinib therapy was safe, without grade 4 adverse events. The most frequent toxicities of all grades were: fatigue (50%), hypertension (26%), and hypothyroidism (18%). G3 blood pressure elevation significantly correlated with longer mPFS and mOS compared to G1-G2 or no toxicity. Dose titration (DT) to 7 mg and 10 mg bid was feasible in 24% with no statistically significant differences in mPFS and mOS. The sunitinib-axitinib sequence was safe and effective, the mOS was 41.15 months. At multivariate analysis, gender, DCR to axitinib and to previous sunitinib correlated significantly with PFS; whereas DCR to axitinib, nephrectomy and Heng score independently affected overall survival.
CONCLUSIONS: Axitinib was effective and safe in a not selected real life mRCC population. Trial registration INT - Napoli - 11/16 oss. Registered 20 April 2016. http://www.istitutotumori.na.it.