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Chemotherapy Updates for
Studies that Involve Taxol(Paclitaxel)
Covered here are
- Taxol
- Taxol and Epirubicin
- Taxol, carboplatin vs Mitoxantrone
- Strontium, Doxorubicin, ketoconazole, Paclitaxel, estramustine.
- Taxol, Vinorelbine (Pac-Vin)(2007 ASCO Annual
Meeting).
Definitions
PR - partial response
Table 1. Taxol (Paclitaxel).
|
Ref |
Phase, Number of Patients |
Paclitaxel |
PSA Response Rate
>50%
Decline.
|
Median Duration of Response |
median survival |
|
(1) |
43, some prior
emcyt use. all metastatic. |
Paclitaxel 80mg/m2 over 1 hour. 6 weeks on and 2 weeks off. |
PSA > 50%
decline: 36.1%, 13 of 36 patients.
Objective
Response: 5 of 16 patients or 31.2%.
9 stable disease. |
PSA: 4.2 months.
|
Median survival 12.8 months |
(1)
Chiappino
I, Destefanis P, Addeo A, Galetto A, Cucchiarale G, Munoz F, Zitella A,
Ferrando U, Fontana D, Ricardi U, Tizzani A, Bertetto O., Activity of weekly
paclitaxel in advanced hormone-refractory prostate cancer, Am J Clin Oncol.
2007 Jun;30(3):234-8.
Toxicities noted are:
anemia grade 3, 16%; neutropenia grade 3-4, 12%) and moderate nonhematologic
toxicities (thrombosis/embolism 10%; fatigue all grades, 60%).
Table 2. Paclitaxel and Epirubicin.
|
Ref |
Phase, Number of Patients |
Paclitaxel and epirubicin |
PSA Response Rate
>50%
Decline.
|
Median Response Rate |
Median time to progression or median survival |
|
(1) |
II, 32 |
Paclitaxel 70mg/m2 and epirubicin 30 mg/m2 every week for three months |
57%
|
- |
Median time to PSA progression 5.5 months; disease progression 7.6
months; survival 12.9 months |
(1)
Neri B, Cipriani G, Fulignati C, Turrini M,
Ponchietti R, Bartoletti R, Della Melina A, Di Cello V, Dominici A, Maleci
D, Raugei A, Villari D, Nicita G. Weekly paclitaxel and
epirubicin in the treatment of symptomatic hormone-refractory advanced
prostate carcinoma: report of a phase II trial. Anticancer Drugs. 2005
Jan;16(1):63-6.
Table 3. Paclitaxel, Carboplatin vs Mitoxantrone(Novantrone).
|
Ref |
Phase, Number of Patients |
Paclitaxel-Carboplatin |
Mitoxantrone |
PSA
Response Rate
>50% |
Median Response Rate |
Median time to progression or median survival |
|
|
(1)* |
II, 34 total (ongoing study) |
Paclitaxel 175 mg/m2 + carboplatin AUC 5 IV on day 1 of every 3 week
cycle |
|
44% 4 of 9 analyzed patients |
|
|
|
|
(1) |
same as above |
|
12 mg/m2 on day 1 of 3 week cycle |
8.3% 1 of 12 analyzed patients |
|
|
|
(1) Cabrespine, L. Guy,
P. Chollet, J. Fleury, F. Gachon, H. Curé, M. Mouret-Reynier, I. Van Praagh,
F. Penault-Llorca, J. Bay Phase II study of paclitaxel carboplatin
combination versus mitoxantrone in patients with hormone-refractory prostate
cancer. Presented at the 2005 Prostate Cancer Symposium, American Society
for Clinical Oncology, 2005.
*Study is
ongoing. Quality of life is not different between the two arms.
Patients
presented higher level of ChroA at includsion have a higher decline
of PSA.
Table 4.
Strontium, Doxorubicin, ketoconazole, Paclitaxel, estramustine.
|
Ref
|
Phase, Number of Patients |
Strontium-89 (S)
doxorubicin (D), ketoconazole (K),
Paclitaxel(P),
estramutine(E) |
PSA
Response Rate
>50% |
Median Response Rate |
Median time to
progression or median survival |
|
(1)* |
None,25 |
S 4 mCi on wk 1 day 1, wks 1,3,5 D 20 mg/m2 first day each wk with K 400
mg 3 times a day for 7 days. Wks 2,4,6 P 100 mg/m2 with E 280 mg orally
3 times a day for 7 days. Responders received 4 8 wk. courses, then
maintenance daily K. |
18 of 20 patients evaluated so far |
- |
Progression free survival range from 2 to 25 months |
(1) H. Henary,
R. J. Amato Bone-Targeted Therapy for Androgen-Independent Prostate Cancer (AIPCa)
Presented at the 2005 Prostate Cancer Symposium, American Society of
Clinical Oncology, 2005. *Enrollment is ongoing.
Table 5.
Paclitaxel (Taxol) and Vinorelbine (Pac-Vin)
|
Ref
|
Phase, Number of Patients |
Paclitaxel |
Vinorelbine |
PSA
Response Rate
>50% |
Measurable
Disease Response Rate |
Median time to
progression or median survival |
|
Sewak et al(1)@, * |
30, II
|
40 mg/m2 (1 hr); days 1 and 8 of 21-day cycle. |
20 mg/m2 I-V; days 1 and 8 of 21-day cycle. |
20% PSA RR, with 63% achieving Stable Disease |
10 patients had measurable disease. PR was 20%; 70% had stable disease. |
Median overall survival was 9.7 months. Median progression free survival
was 5.1 months. |
(1)
S.
Sewak, S. Kosmider, V. Ganju, A. Woollett, B. Le, E. Yeo, M. Henry, R. Bell,
A phase II study of paclitaxel and vinorelbine (Pac-Vin) in
hormone-refractory metastatic prostate cancer (HRPC): A final update,
Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Part I.
Vol 25, No. 18S (June 20 Supplement), 2007: 15505. Note that pre-clinical
models had shown synergy between paclitaxel and vinorelbine.
@Previous radiotherapy, strontium therapy, 1 line of chemotherapy (17% had 1
prior chemotherapy), and concurrent bisphosphonate therapy were allowed.
*Grade 3&4 toxicities were: neutropenia 8%, febrile neutropenia 4%,
infection 2%, anemia 3%, lethargy 1%, and somnolescence 1%. 1 pt died as a
result of neutropenic sepsis.
Author: Barb Minton, 3/16/2005; Updated 10/17/07 H. Hansen
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