|
Chemotherapy Updates for
non-taxane or non-sequential
The following
studies are covered: Carboplatin plus etoposide; DPPE + Mitoxantrone; tamoxifen; emcyt; Mitoxantrone; vinorelbine; etoposide; Xeloda; Uracil/Tegafur;
Irofulven; Satraplatin; Gefitinib(Iressa); Chlorambucil + lomustine; JM-216; Cyclophosphamide (C) + Etoposide
(E) + Estramustine (E); Dexamethasone + Calcitriol + Carboplatin, Epirubicin
combinations and oral cyclophosphamide combinations.
Table 1a. Carboplatin and
etoposide (2007) as a 2nd line chemotherapy.
|
Reference |
Patients,
Phase |
Carboplatin |
Etoposide |
PSA RR
(≥ 50% decrease) |
Pain Relief RR |
Median Progression
Free Survival |
Median Overall
Survival |
|
(1) Y. Loriot et al,
ASCO 2007, #5151. |
41; -.
24 prior docetaxel
plus emcyt;
17 prior docetaxel only.
|
AUC 5, day 1,
Every 3 weeks |
80mg/m2, days 1,2, and
3. Every 3 weeks. |
22% (9 patients) |
45% (18 patients) |
9 weeks |
19 months. |
(1)
Y. Loriot, C.
Massard, A. Plantade, B. Escudier, A. Chauchereau, R. De Crevoisier, K.
Fizazi, A prospective study of carboplatin-etoposide in docetaxel-pretreated
patients with hormone-refractory prostate cancer (HRPC): Clinical activity
and correlation with neuroendocrine features, Journal of Clinical Oncology,
2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June 20
Supplement), 2007: 5151
* Serum chromogranin A and neurone specific enolase (NSE) levels were
measured at baseline.
* Elevated baseline serum
chromogranin A and NSE were not associated with response or PFS. The
response rate was 18% (normal baseline CgA) and 31% (elevated baseline CgA).
* Toxicity included grade
3-4 anemia in 25% and febrile neutropenia in 2%.
Table 1.
Tesmilifene and Mitoxantrone.
|
Ref |
Phase, Number of Patients |
Tesmilifene
(DPPE)l |
Mitoxantrone |
Prednisone |
PSA
Response Rate
>50% |
Median Response Rate |
Median time to progression or median survival |
|
(1) |
II,29 |
5.3mg/kg every three weeks |
12mg/m
Every week (?) |
5 mg twice daily |
59% |
Not reported |
Actual 2 year survival was 21% |
(1) Raghavan D,
Brandes LJ, Klapp K, Snyder T, Styles E, Tsao-Wei D, Lieskovsky
G, Quinn DI,
Ramsey EW. Phase II trial of tesmilifene plus mitoxantrone and
prednisone for
hormone refractory prostate cancer: high subjective and
objective
response in patients with symptomatic metastases. J Urol. 2005
Nov;174(5):1808-13; discussion 1813.
Table 2. Tamoxifen.
|
Ref |
Phase, Number of Patients |
Tamoxifen |
PSA
Response Rate
>50% |
Median Response Rate |
Median time to progression or median survival |
|
(1)* |
II, 14 |
20 mg daily
orally |
29% |
Not reported |
Not reported |
(1) Lissoni P, Vigano P, Vaghi M, Frontini L, Guiberti C,
Manganini V, Casu M,
Brivio F, Niespolo R, Strada G. A phase II study of
tamoxifen in hormone-resistant metastatic prostate cancer: possible relation
with prolactin secretion. Anticancer Res. 2005 Sep-Oct;25(5):3597-9.
*Mean pre-treatment levels of prolactin were higher in
those who responded to treatment.
Table 3. Emcyt, Mitoxantrone, vinorelbine,
etoposide.
|
Ref |
Phase, Number of Patients |
Emcyt |
Mito-
xantrone
|
Vinorelbine
|
Etoposide |
PSA
Response Rate
>50% |
Median Response Rate |
Median time to progression or median survival |
|
(1) |
II, 52 |
Capsules of 140 mg 3 times daily on days 1 to 3 and days 8 to 10 |
12mg/m2
on day 2 |
25 mg/m2 on day 2 and day 9 |
- |
56% |
Not reported |
Median duration of response 6.9 months; Median survival 14.5 months |
|
(2) |
II,51 |
600 mg/m2 daily |
- |
i.v. 25 mg/m2 days 1 and 8 every 3 weeks |
- |
45% |
Not reported |
Progression free 4.7 months (range 1.9-8.6); overall survival 14.3
months (range 4.2-21.2) |
|
(3)* |
II, 46 |
560 mg per day for 20 days, then 7 day rest period |
- |
- |
100 mg per day |
54% attained a PSA response |
- |
Median time to progression 7.4 months; median survival 18.4 months |
(1)Samelis GF, Kalofonos H, Adamou A, Kosmides P, Skarlos D, Aravantinos
G, Kiamouris C, Adimchi O, Fountzilas G, Dimopoulos AM. The combination of
estramustine, vinorelbine, and mitoxantrone in hormone-refractory prostate
cancer: a Phase II feasibility study conducted by the Hellenic Cooperative
Oncology Group. Urology. 2005 Aug;66(2):382-5
(2)Carles Galceran J, Bastus Piulats R, Martin-Broto J, Maroto Rey P, Nogue
Aligue M, Domenech Santasusana M, Arcusa Lanza A, Bellmunt Molins J, Colin C
Girard A. A phase II study of vinorelbine and estramustine in patients with
hormone-resistent prostate cancer. Clin Transl Oncol. 2005 Mar;7(2):66-73.
(3)Berruti A, Fara E, Tucci M, Tarabuzzi R, Mosca A, Terrone C, Gorzegno G,
Fasolis G, Tampellini M, Porpiglia F, De Stefanis M, Fontana D, Bertetto O,
Dogliotti L. Oral estramustine plus oral etoposide in the treatment of
hormone refractory prostate cancer patients: a phase II study with a 5-year
follow-up. Urol Oncol. 2005
Jan-Feb;23(1):1-7.
*30% of patients had a time to progression of 12
months and 20% had a time to progression greater than 18 months. 35%
survived more than 2 years. One patient was alive and free from
progression after 7 years.
Table 4. Capecitabine (Xeloda). See also
Xeloda(capecitabine).
|
Ref |
Phase, Number of Patients |
Fluoropyrimidine
Capecitabine |
PSA
Response Rate
>50% |
Median Response Rate |
Median time to progression or median survival |
|
(1) |
II, 14 |
1250 mg/m2 twice daily for two weeks of a three week cycle |
Not reported; 1 of 14 patients had a partial RR, 50% of patients had a
decrease in rate of PSA rise |
- |
36% sustained PSA stabilization beyond 18 weeks, 1 patient to 24 weeks |
(1)
Spicer J,
Plunkett t, Somaiah N, Chan S, Kendall A, Bolunwu N, Pandha H.
Phase II study of oral
capecitabine in patients with hormone-refractory prostate cancer.
Prostate Cancer Prostatic
Dis. 2005;8(4):364-8.
Table 5. Uracil/Tegafur.
|
Ref
|
Phase, Number of Patients |
Uracil/tegafur |
PSA
Response Rate
>50% |
Median Response Rate |
Median time to progression or median survival |
|
(1)* |
None,68 |
300-600 mg/day |
Not reported, reduction in PSA in 60.3% ; 19% were regarded as
responders |
7 months – range 1 to 22 months |
- |
(1)
Miyake H,
Hara I, Yamazaki H, Eto H. Clinical outcome of oral uracil/tegafur (UFT)
therapy for patients with hormone refractory prostate cancer. Oncol Rep.
2005 Sep;14(3):673-6. *Patients without
bone mets or whose PSA was less than 2.0 showed a significantly
higher incidence of PSA response to UFT.
Table 6. Irofulven.
|
Ref
|
Phase, Number of Patients |
Irofulven |
PSA
Response Rate
>50% |
Objective RR * |
Median time to progression or median survival |
|
(1)* |
II, 42. |
10.6 mg/m2 on days 1-5 of a 28 day course (median of 3 courses received) |
- |
- |
Median progression-free survival 4.2 months for responders |
|
(2) Berger ER, et al, ASCO 2007, Abs 5068. |
II, 134, randomized. All patients had failed taxotere. Irofulven vs
Irofulven plus capecitabine vs mitoxantrone. Each arm included
prednisone.
Arm A/B/C: 53/54/27 |
Arm A: IROF (0.45 mg/kg, Day [D]1, 8 every [q] 3 weeks [w]) and
prednisone (PRED; 10 mg qd); |
10% |
10% |
Median OS
10.1 mos.; Median TTP
2.2 mos. |
|
Arm B: IROF (0.4 mg/kg D1, 15), capecitabine (CAPE; 2,000 mg/m2 D1-15
q4w) and PRED; |
22% |
10% |
Median OS
9.5 mos.
Median TTP
3.8 mos. |
|
Arm C: MITOX (12 mg/m2 q3w) and PRED. |
0% |
13% |
Median OS
7.4 mos.
Median TTP
1.8 mos. |
(1)
Senzer N,
Arsenau J, Richards D, Berman B, MacDonald JR, Smith S. Irofulven
demonstrates clinical activity against metastatic hormone-refractory
prostate cancer in a phase 2 single-agent trial. Am J Clin Oncol. 2005
Feb;28(1):36-42. *84% of patients had disease stabilization. The authors
suggest further investigation in combination therapies.
(2)
E. R. Berger, T. Ciuleanu, L. Hart, K. N. Chi, J. Alexandre, S. Oudard, C.
Kahatt, G. Weems, E. Cvitkovic, J. R. MacDonald, Results of a randomized
phase II study of irofulven in hormone-refractory prostate cancer patients
that have failed first-line docetaxel treatment, Journal of Clinical
Oncology, 2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June
20 Supplement), 2007: 5068. * RECIST responses measure a tumor's shrinkage
as the decrease in the length of its largest diameter.
RECIST responses 10%/10%/13%, . Safety:
Treatment was well tolerated in all arms. The most frequent Grade 3-4
toxicities (% pts) were asthenia (8%/15%/0%), and vomiting (4%/11%/0%).
Grade 3-4 hematological events included neutropenia (22%/15%/61%) and
thrombocytopenia (23%/21%/4%). Conclusions: Results to date indicate longer
survival, longer TTP, and greater PSA response for IROF/PRED and IROF/CAPE/PRED
compared to MITOX/PRED. Based on these data, a larger randomized trial of
irofulven in docetaxel resistant HRPC
Table 7. Satraplatin. Satraplatin is still in clinical
trials and is only available in a trial. It is being developed as a 2nd line
chemotherapy. See the page on Satraplatin.
Satraplatin failed its phase III trial as it did not show any survival
advantage of Satraplatin/prednisone over prednisone alone. As a
result, at this time (10/31/07) they have discontinued development of
Satraplatin for HRPC.
|
Ref |
Phase, Number of Patients |
Satraplatin |
Prednisone |
PSA
Response Rate
>50% |
Median Response Rate |
Median time to progression or median survival |
|
(1) |
III,50 (25 in each treatment group) |
Satraplatin 100 mg/m2 for 5 days |
10 mgs orally twice daily |
33.3% |
- |
Progression free survival 5.2 months; median survival 14.9 months
|
|
(1) |
III,50 (25 in each treatment group) |
- |
10 mg orally twice daily |
8.7% |
- |
Progression free survival 2.5 months; median survival 11.9 months |
(1)
Sternberg
CN, Whelan P, Hetherington J, Paluchowska B, Slee PH, Vekemans K, Van Erps
P, Theodore C, Koriakine O, Oliver T, Lebwohl D, Debois M, Zurlo A, Collette
L. Phase III trial of satraplatin, an oral platinum plus prednisone vs.
prednisone alone in patients with hormone-refractory prostate cancer.
Oncology. 2005;68(1):2-9. Epub 2005 Feb 28.
Table 8. Gefitinib.
Iressa
= gefitinib, targets a molecule called epidermal growth factor receptor.
|
Ref |
Phase, Number of Patients |
gefitinib |
PSA
Response Rate
>50% |
Median Response Rate |
Median time to progression or median survival |
|
(1) |
II, 19 |
250 mg orally daily |
0% ;1 patient had stable PSA |
|
|
|
(1) |
II, 21 |
500 mg orally daily |
0%; 4 patients had stable PSA |
|
|
(1)
Canil CM, Moore MJ, Winquist E, Baetz T,
Pollak M, Chi KN, Berry S, Ernst DS, Douglas L, Brundage M, Fisher B,
McKenna A, Seymour L. Randomized phase II study of two doses of
gefitinib in hormone-refractory prostate cancer: a trial of the National
Cancer Institute of Canada-Clinical Trials Group. J Clin Oncol. 2005 Jan
20;23(3):455-60.
Table 9.
Chlorambucil and lomustine.
|
Ref |
Phase, Number of Patients |
Chlorambucil and lomustine |
PSA
Response Rate
>50% |
Median Response Rate |
Median time to progression or median survival |
|
(1)* |
II, 37 |
Chlorambucil 1 mg kg(-1) given as 6 mg a day until total dose reached;
lomustine 2 mg kg(-1) every 56 days (all hormone therapy stopped) |
10% |
- |
Median time to progression 3.6 months; overall survival 7.1 months |
(1)
Shamash J, Dancey G, Barlow C, Wilson P,
Ansell W, Oliver RT. Chlorambucil and lomustine
(CL56) in absolute hormone refractory prostate cancer: re-induction of endocrine sensitivity an unexpected
finding. Br J Cancer. 2005 Jan 17;92(1):36-40. * 47% (8 of 17 patients) who restarted hormonal therapy
following failure of chemotherapy had a further PSA reduction, three of
which were >50%. Median progression free interval for the 8 patients was
4 months.
Table 10.
JM-216 (oral bis (aceto) ammine dichloro (cyclohexamine) platinum (IV)).
|
Ref |
Phase, Number of Patients |
JM-216 (oral bis (aceto) ammine dichloro (cyclohexamine) platinum (IV)) |
PSA
Response Rate
>50% |
Median Response Rate |
Median time to progression or median survival |
|
(1)* |
II, 39 |
120 mg/m2/d administered orally for five days every 4 weeks |
- |
- |
- |
(1)
Latif T, Wood L, Connell C, Smith DC, Vaughn
D, Lebwohl D, Peereboom D.
Phase II study of
oral bis (aceto) ammine dichloro (cyclohexamine) platinum
(IV) (JM-216,
BMS-182751) given daily x 5 in hormone refractory prostate
cancer (HRPC).
Invest New Drugs. 2005 Jan;23(1):79-84.
*PSA response was
assessed in 32 patients, 26% had a partial response, 36%
had stable
disease, 21% had PSA progression. “Although JM-216 had
moderate activity
in HRPC when given on a daily basis for five days, it is
associated with
significant treatment related toxicities.”
Table 11.
Cyclophosphamide (C), Etoposide (E), Estramustine
|
Ref |
Phase, Number of Patients |
Cyclophosphamide (C), Etoposide (E), Estramustine (E) |
PSA
Response Rate
>50% |
Median Response Rate |
Median time to progression or median survival |
(1)
|
II, 24
|
C 50 mg/m2 p.o., Etoposide 50 mg/m2 p.o., and estramustine 280 mg p.o. on days
1-14 every 28 days.
|
28%
|
-
|
Not been reached; study is ongoing
|
(1) M. A.
Choudry, D. A. Laber, G. H. Kloecker, A. C. Mehta, C. Crump, L. Bhupalam,,
R. V. La Rocca, V. R. Sharma, F. J. Hendler, D. M. Miller Phase II Study of
cyclophosphamide, etoposide and estramustine in patients with androgen
independent prostate cancer. Presented at the 2005 Prostate Cancer Symposium
of the American Society of Clinical Oncology, 2005. *The authors comment that is in an all oral regimen.
Table 12.
Dexamethasone, Calcitriol, Carboplatin.
|
Ref |
Phase, Number of Patients |
Dexamethasone, Calcitriol, Carboplatin |
PSA
Response Rate
>50% |
Median Response Rate |
Median time to progression or median survival |
(1)*
|
II,34
|
1 mg oral dexamethasone daily; .5 mcg of daily Calcitriol added at week
5, Carboplatin (AUC = 2) started week 7 for the first 4 weeks of a 6
week cycle.
|
38%
|
-
|
-
|
(1) T. Flaig,
A. B. Barqawi, M. Kane, G. Miller, E. D. Crawford, L. M. Glode A Phase II
Trial of Dexamethasone, 1,25-Dihydroxyvitamin D and Carboplatin in Patients
With Hormone Refractory Prostate Cancer. Presented at the 2005 Prostate
Cancer Symposium, American Society for Clinical Oncology, 2005.
*At 4 weeks (after dexamethasone treatment alone) 7 patients had PSA
response, at 6 weeks (after the addition of calcitriol for two weeks) 1 more
patient showed PSA response, at 12 weeks or later 5 additional patients had
PSA response.
A
PSA reduction of any magnitude was seen in 68% of patients.
Table 13.
Epirubicin Combinations.
|
Ref |
Phase, Number of Patients |
Epirubicin |
Drug Combined
with epirubicin |
PSA
Response Rate
>50% |
Median Response Duration
(MDR) |
Median time to progression or median survival |
(1)
|
Not reported, 30
|
Weekly epirubicin 25 mg/sqm for 24 administrations
|
filgrastim 300 mg
(?) once a week since the first episode of neutropenia, then twice a
week |
PR 26.7%, MR 13.3%, SD 36.7%, PD 23.3%.
Overall response rate 40%
|
|
Overall survival 15.5 months (range 5-23)
|
|
(2) |
-, 38 evaluable patients. |
Weekly epirubicin, 30mg/m2, 24 cycles.
|
Taxotere (Docetaxel), weekly, 30mg/m2, 24 cycles. |
68.4% (26 patients). |
8.8 mos. |
TTP 7.4 mos.
|
(1) M. Ranuzzi,
F. Vetta, F. Russo. Hormone-refractory prostate cancer (HRPC): Weekly
epirubicin (EPI) in elderly patients.. Presented at 2005 Prostate Cancer
Symposium, American Society for Clinical Oncology, 2005.
(2)
Petrioli R, Paolelli L, Francini E, Manganelli A, Salvestrini F, Francini
G., Weekly docetaxel and epirubicin in treatment of advanced
hormone-refractory prostate cancer, Urology 2007 Jan;69(1):142-6. The
therapy was discontinued after the first 12 cycles in the patients who
responded or had stable disease and was resumed as soon as any signs of
progression were noted. Pain response for 33 symptomatic patients was 72.7%.
21 of 38 resumed treatment after planned interruptions. 3 of 21 had PSA
responses (14.2%) and 12 had stable disease (57.1%). Adverse events: Grade 3
neutropenia occurred in 15.7% of the patients, grade 3 anemia in 13.1%, and
grade 3 thrombocytopenia in 7.8%.
Table 14.
Oral cyclophosphamide combinations.
|
Ref
|
Phase, Number of Patients |
Oral cyclophosphamide (CP) |
Other Drugs Added
to CP |
Response Rate.
PSA ≥
50% decrease |
Median Duration of Response |
Median time to progression or median survival |
(1)Cheong
KA et al 2005, ASCO PC symp.
|
?, 21
|
50 mg daily
|
- |
-
|
-
|
Median time to progression 6.3 months; median survival 12.9 months
|
(2)Nelius T et al, ASCO 2007.
|
-, 17.
All patients had failed 1st line taxotere
|
50 mg daily, until disease progression.
|
Dexamethasone, 1mg daily, until disease progression.
|
PSA RR
(median 44.4%), 4 pts = 50% and 5 pts < 50%
|
|
TTP/survival for pts with PSA response and PSA progression was 24/60
weeks and 4/4 weeks, respectively.
|
(3) Pecora A, et al. The Prostate J. 2001.
|
-, 27 (all chemo-naive)
|
oral,
100mg/m2, days 1-14.
|
Ketoconazole 400mg TID, hydrocortisone 20mg am/10mg pm both on days
1-28.
|
PSA RR 21/27 (78%).
|
9 months (range 3 to >96 months).
|
-
|
(4) Lord R, et al, J. Urology 2007
|
II, 80 (58 evaluable)
chemo-naive.
|
oral, 50mg/m2 continuous in 4 weekly cycles without breaks for a total
of 12 cycles.
|
-
|
34.5%
inclusive of objective and PSA parameters.
|
7.5
months (range 3 to 18)
|
Median survival not yet reached.
|
(5) Nicolini A, et al, Biomedecine & Pharm 2004.
|
-, 8.
2 - chemo-naive.
3 - 1 prior chemo.
3 - 2 prior chemos
|
oral, 100-150mg/day alternately until progression or toxicity.
Mesna 400mg/day po 3 weeks on one off.
|
-
|
% decreases:
31%,
97%,
12%,
45%,
31% in the 5 responders.
|
|
OS(months):
13, 17, 9, 17, 41 in
responders measured from start of cyclophos. |
|
(6) Glode LM et al, Cancer
2003. |
Retrospective,
34. Some not chemo-naive. 32
available for analysis.
|
oral, 50mg/day. |
dexamethasone, 1mg/day. |
> 80%: 28%.
50-80% decrease: 41%.
<50%:
6%.
|
8 months |
TTP: 9 months.
|
|
(7) Hellerstedt et al, Cancer 2003 |
Phase II, 37 pts. Previous chemo allowed. |
100 mg per day on Days 1-20 on 30 day cycle. |
prednisone 10 mg per day
continuously, and DES 1 mg continuously, on a 30-day cycle.
Warfarin 1 mg per day was
given as prophylaxis for thrombosis.
|
15 of 36 pts (42%) had a PSA response. |
4.5 mos. (4-18 mos. range) |
Overall Median survival was 16.4 mos. |
(
(1) K. A.
Cheong, K. Chrystal, P. G. Harper A single centre retrospective review of
oral cyclophosphamide in hormone-refractory prostate cancer. Presented at
the 2005 Prostate Cancer Symposium, American Society for Clinical Oncology,
2005.
* Since this a very nontoxic therapy it can be considered for use in the
elderly and frail.
*
Subjects in this study had co-morbidities that made
standard chemotherapy unsuitable.
(2)
T. NELIUS, T. Klatte, W. de Riese, S. Filleur, Clinical outcome of patients
(pts) with taxane-resistant (TR) hormone-refractory prostate cancer (HRPC)
treated with second-line cyclophosphamide (CP) -based metronomic
chemotherapy. Journal of Clinical Oncology, 2007 ASCO Annual Meeting
Proceedings Part I. Vol 25, No. 18S (June 20 Supplement), 2007: 15647.
3 pts of the progression group showed a decrease in PSA doubling time.
Resonses attributed to metronomic dosing and anti-angiogenesis.
(3) Andrew Pecora, Frank Richter, Anna Pavlick, Vincent Lanteri, John Scheuch, Stuart Levy,
Gene Rosenberg, and Jack Vitenson; Treatment of Metastatic Hormone Refractory Prostate Cancer with Ketoconazole,
Hydrocortisone, and Cyclophosphamide, The Prostate Journal, Volume 3 Issue 2
Page 71 - April/May/June 2001. and Pavlick AC, Pecora AL, Scheuch J, et al:
Treatment of hormone refractory prostate cancer with ketoconazole,
hydrocortisone and cyclophosphamide. Proc Amer Soc Clin Oncol 15:698a, 1996.
(4) Lord R, Nair S, Schache A, Spicer J, Somaihah N, Khoo V, Pandha H., Low
dose metronomic oral cyclophosphamide for hormone resistant prostate cancer:
a phase II study, J. Urol. 2007 Jun;177(6):2136-40; discussion 2140. Note:
32.8% had grade 3 lyphopenia. No exacerbation of urinary symptoms, nl
evidence of hematuria on urine testing. As part of their conclusion, they
said, "The
efficacy, low toxicity, low cost and ease of administration of
cyclophosphamide
justifies further studies in prostate cancer in combination with other
agents."
(5) A.
Nicolini et al, Oral Low-Dose cyclophosphamide in Metastatic Hormone
Refractory Prostate Cancer (MHRPC), Biomedicine & Pharmacotherapy, Vol 58,
Issue 8, October 2004, pp 447-450.
Prior chemotherapies were either emcyt or emcyt plus vinblastine. Overall
clinical benefit was 62.5% and median duration 9 months. Toxicity grade 2 or
3 neutropenia and in 50% pulmonary and urinary infections (mainly cyctitis
with and without hemorrhage).
(6)
Glode LM, Barqawi A, Crighton F, Crawford ED, Kerbel R., Metronomic therapy
with cyclophosphamide and dexamethasone for prostate carcinoma, Cancer. 2003
Oct 15;98(8):1643-8. Comment in: Cancer. 2003 Oct 15;98(8):1559-61.
(7) Beth
Hellerstedt, M.D., et al, Phase II Trial of Oral Cyclophosphamide,
Prednisone, and Diethylstilbestrol for Androgen-Independent Prostate
Carcinoma, Cancer 2003;98:1603–10.
Previous chemotherapy was
allowed. 4 of 15 patients (26%) who had received previous chemotherapy had a
greater-than-50% decline in PSA levels, compared with 11 of 21 (52%)
patients who had not received previous chemotherapy.
Median time to response was 2 cycles.
They also found that the PSA response could be quite gradualwith it taking
1-13 months to see a maximal decrease in PSA level.
Authors: Barb Minton (original tables) and Howard Hansen
(2007 updates)
|
