Konference: 2008 33st Congress ESMO - účast ČR
Kategorie: Zhoubné nádory plic a průdušek
Téma: Chest tumors
Číslo abstraktu: 296P
Autoři: prof. MUDr. Petr Zatloukal (1955-2012), CSc.; A. Mellemgaard; J. M. Sánchez; M.C. Perry; J.T. Hamm; J. Van Meerbeeck; J.J. DeLeo; B. Gao; A.R. Johri; Enriqueta Felip, MD, PhD
Background: The prognosis of inoperable, advanced NSCLC
remains poor with 5-year survival rates being less than 5%
following combination chemotherapy. Patupilone,a novel epothilone,
is a microtubule stabilizing agent showing clinical activity in pts
with a wide range of tumors, including those with brain metastases
(BM) and taxaneresistant tumors.
Methods: This open-label, multi-center, Phase II study used a Simon 2-stage (St)design to evaluate the efficacy and safety of patupilone for patients (pts) with locally advanced or metastatic NSCLC and post-chemotherapy progression. Eligible pts received patupilone 10 mg/m2 IV over 20 mins once every 3 wks. Response rate and time to progression were assessed by CT scan every 6 wks (RECIST criteria). Criteria to proceed to St 2 were responses in 2/21 pts. A separate cohort of 4 pts with documented BM was also treated.
Results: Between Sep 2005 and Nov 2007 39 pts were enrolled. Preliminary data from the 39 pts enrolled (St I: 22; St II: 13; and BM: 4) are presented. Median age was 63 years (range: 44–77); 70% were male. The median number of cycles was 3 (range: 1-10). Regardless of relationship, the most common adverse events (AEs) were diarrhea 77%, vomiting 28%, abdominal pain 28%, and asthenia 26%; and the most frequent G3/4 AEs were diarrhea 31%, dehydration 8%, dyspnea 8%, pneumonia 8% and abdominal pain 5%. There were no G3/4 hematological toxicities reported. Preliminary efficacy data were available for 24 pts (21 St 1, 3 BM): 3 PR, 6 SD, and 15 PD. Median time to progression: 2.6 months (95% CI, 1.8, 3.9). Efficacy data on 15 pts will be updated.
Conclusion: St I criteria of 2 documented responses (CR, PR) in 22 pts were met to proceed to St 2. Patupilone at an IV dose of 10 mg/m2 once every 3 wks shows an acceptable safety profile with preliminary results suggesting evidence of anti-tumor activity in pretreated pts with locally advanced or metastatic NSCLC.
Methods: This open-label, multi-center, Phase II study used a Simon 2-stage (St)design to evaluate the efficacy and safety of patupilone for patients (pts) with locally advanced or metastatic NSCLC and post-chemotherapy progression. Eligible pts received patupilone 10 mg/m2 IV over 20 mins once every 3 wks. Response rate and time to progression were assessed by CT scan every 6 wks (RECIST criteria). Criteria to proceed to St 2 were responses in 2/21 pts. A separate cohort of 4 pts with documented BM was also treated.
Results: Between Sep 2005 and Nov 2007 39 pts were enrolled. Preliminary data from the 39 pts enrolled (St I: 22; St II: 13; and BM: 4) are presented. Median age was 63 years (range: 44–77); 70% were male. The median number of cycles was 3 (range: 1-10). Regardless of relationship, the most common adverse events (AEs) were diarrhea 77%, vomiting 28%, abdominal pain 28%, and asthenia 26%; and the most frequent G3/4 AEs were diarrhea 31%, dehydration 8%, dyspnea 8%, pneumonia 8% and abdominal pain 5%. There were no G3/4 hematological toxicities reported. Preliminary efficacy data were available for 24 pts (21 St 1, 3 BM): 3 PR, 6 SD, and 15 PD. Median time to progression: 2.6 months (95% CI, 1.8, 3.9). Efficacy data on 15 pts will be updated.
Conclusion: St I criteria of 2 documented responses (CR, PR) in 22 pts were met to proceed to St 2. Patupilone at an IV dose of 10 mg/m2 once every 3 wks shows an acceptable safety profile with preliminary results suggesting evidence of anti-tumor activity in pretreated pts with locally advanced or metastatic NSCLC.
Datum přednesení příspěvku: 12. 9. 2008
