Wpływ liczby wlewów Docetakselu na całkowite przeżycie (OS).

Wpływ liczby wlewów Docetakselu na całkowite przeżycie (OS).

Nieprzeczytany postautor: wlobo135 » 17 wrz 2016, 23:45

Do niedawna nie było badań nad optymalną liczbą cykli Docetakselu u pacjentów z rozsianym hormonoodpornym rakiem prostaty (mCRPC) zakwalikowanych do ChT. Niedawno zakończono wielonarodowe randomizowane badanie fazy 3 na 1059 pacjentach z mCRPC.


Wyniki badania wskazują że większa liczba wlewów Docetakselu przedłuża OS.
U pacjentów którzy otrzymali więcej niż 10 cykli mediana OS wynosiła 33,0 miesiące,
w porównaniu z 26,9 miesiąca u pacjentów leczonych 8 do 10 cykli;

U pacjentów, którzy otrzymali od 5 do 7 cykli mediana OS wynosiła 22,8 miesięcy.
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Re: Wpływ ilości wlewów Docetakselu na całkowite przeżycie (

Nieprzeczytany postautor: zosia bluszcz » 18 wrz 2016, 01:50

wlobo135 pisze:Do niedawna nie było badań nad optymalną liczbą cykli Docetakselu u pacjentów z rozsianym hormonoodpornym rakiem prostaty (mCRPC) zakwalikowanych do ChT. Niedawno zakończono wielonarodowe randomizowane badanie fazy 3 na 1059 pacjentach z mCRPC.




Wyniki, o ktorych pisze Wlodek wyszly niejako przypadkowo z przerwanego badania MAINSAIL dotyczacego skutecznosci i bezpieczenstwa Lenalidomidu w polaczeniu z Docetaxelem (+ Prednison). Badanie bylo randomizowane a pacjenci otrzymywali:

Docetaxel, prednison, and Lenalidomid (dawny Thalidomid) (DPL)
lub
Docetaxel, prednison i placebo

Opracowanie prezentujace obiecujace wyniki jest analizą ad hoc a zaleznosc OS od ilosci cykli Docetaxelu wymaga dalszych badan.



Association of Survival Benefit With Docetaxel in Prostate Cancer and Total Number of Cycles Administered: A Post hoc Analysis of the Mainsail Study
AMA Oncol. 2016 Aug 25.

Abstract
IMPORTANCE:
The optimal total number of docetaxel cycles in patients with metastatic castration resistant prostate cancer (mCPRC) has not been investigated yet.
It is unknown whether it is beneficial for patients to continue treatment upon 6 cycles.


OBJECTIVE:
To investigate whether the number of docetaxel cycles administered to patients deriving clinical benefit was an independent prognostic factor for overall survival (OS) in a post hoc analysis of the Mainsail trial.

DESIGN, SETTING, AND PARTICIPANTS:
The Mainsail trial was a multinational randomized phase 3 study of 1059 patients with mCRPC receiving docetaxel, prednisone, and lenalidomide (DPL) or docetaxel, prednisone, and a placebo (DP).
Study patients were treated until progressive disease or unacceptable adverse effects occurred.
Median OS was found to be inferior in the DPL arm compared with the DP arm.

As a result of increased toxic effects with the DPL combination, patients on DPL received fewer docetaxel cycles (median, 6) vs 8 cycles in the control group.
As the dose intensity was comparable in both treatment arms, we investigated whether the number of docetaxel cycles administered to patients deriving clinical benefit on Mainsail was an independent prognostic factor for OS.
We conducted primary univariate and multivariate analyses for the intention-to-treat population. Additional sensitivity analyses were done, excluding patients who stopped treatment for reasons of disease progression and those who received 4 or fewer cycles of docetaxel for other reasons, minimizing the effect of confounding factors.

MAIN OUTCOMES AND MEASURES:
Total number of docetaxel cycles delivered as an independent factor for OS.

RESULTS:
Overall, all 1059 patients from the Mainsail trial were included (mean [SD] age, 68.7 [7.89] years).
Treatment with 8 or more cycles of docetaxel was associated with superior OS (hazard ratio
, 1.909; 95% CI, 1.660-2.194; P < .001), irrespective of lenalidomide treatment (HR, 1.060; 95% CI, 0.924-1.215; P = .41).
Likewise, in the sensitivity analysis, patients who received a greater number of docetaxel cycles had superior OS; patients who received more than 10 cycles had a median OS of 33.0 months compared with 26.9 months in patients treated with 8 to 10 cycles; and patients who received 5 to 7 cycles had a median OS of 22.8 months (P < .001).

CONCLUSIONS AND RELEVANCE:
These findings suggest that continuation of docetaxel chemotherapy contributes to the survival benefit. Prospective validation is warranted.[/i]
http://www.ncbi.nlm.nih.gov/pubmed/27560549



Informacja dotyczaca przerwania badania MAINSAIL:

[i]Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer -
Detailed Description:
In November 2011, the Data Monitoring Committee concluded it was unlikely that the study would meet its primary endpoint of overall survival (OS) and recommended that the study be stopped. The study was terminated in accordance with this recommendation. All sites were instructed to immediately discontinue all patients from experimental lenalidomide/placebo treatment administered either in combination with chemotherapy or as a single agent following chemotherapy discontinuation.

Subsequently, Protocol Amendment 3 was issued to provide for the following:

=> To continue to collect information on Second Primary Malignancies (SPMs) and additional treatments for Prostate Cancer in all randomized subjects during survival follow-up.

=> To continue to provide docetaxel and prednisone for up to 10 cycles to subjects randomized at non-US sites who were ongoing in the CC-5013-PC-002 protocol when the decision was made to discontinue lenalidomide/placebo and who were experiencing benefit as per investigator discretion.
For subjects who had exceeded 10 cycles of docetaxel and prednisone at the time of Protocol Amendment 3 approval, an additional two cycles were provided.


All references to dosing and study procedures pertaining to the safety, efficacy, and exploratory endpoints of lenalidomide/placebo were discontinued as part of Protocol Amendment 3.

https://clinicaltrials.gov/ct2/show/NCT00988208
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