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Õèìèîòåðàïèÿ ìåòàñòàòè÷åñêîãî ðàêà ïîäæåëóäî÷íîé æåëåçû
Äîáðîãî âðåìåíè ñóòîê.
Õîòåëîñü áû óçíàòü ìíåíèå î ñõåìàõ õèìèîòåðàïèè ðàêà ïîäæåëóäî÷íîé æåëåçû ñ ìåòàñòàçàìè â ïå÷åíü. (Íà äíÿõ ýòîò äèàãíîç ïîñòàâèëè áëèçêîìó äðóãó íàøåé ñåìüè, ñòîèò âîïðîñ î íà÷àëå õèìèîòåðàïèè). Îáçîðû íàøëà òîëüêî çà 2011ã (ÿ íåâðîëîã), ïðàâèëüíî ëè ÿ ïîíèìàþ, ÷òî íà ñåãîäíÿøíèé äåíü, ïðè óñëîâèè õîðîøåãî ñîìàòè÷åñêîãî ñîñòîÿíèÿ, ñàìûì ïåðñïåêòèâíîé ñõåìîé, ñ íàèáîëüøèì âðåìåíåì âûæèâàíèÿ ÿâëÿåòñÿ ôîëôèðèíîêñ(ôòîðóðàöèë+ôîëèåâàÿ êèñëîòà+èðèíîòåêàí+îêñàëèïëàòèí) ? Òàê æå ñõåìà ãåìöèòàáèí+êàïåöèòàáèí áîëåå âûãîäíàÿ, ÷åì ãåìöèòàáèí, íî íå òàê ýôôåêòèâíà êàê ôîëôèðèíîêñ? Ïîíÿòíî, ÷òî ðåøàòü ýòè âîïðîñû ñ ëå÷àùèìè îíêîëîãàìè, íî õîòåëîñü áû óçíàòü âàøå ìíåíèå, êàêèå ñõåìû âû ñ÷èòàåòå ñàìûìè âûãîäíûìè, ïðè óñëîâèè õîðîøåãî ñîñòîÿíèÿ áîëüíîãî, êàêèå èñïîëüçóåòå? |
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Öèòàòà:
Ñòàíäàðòíûìè ÿâëÿþòñÿ ñõåìû ñîäåðæàùèå Ãåìöèòàáèí (Ãåìçàð), âîçìîæíî ñ äîáàâëåíèåì ïëàòèíû.  ëþáîì ñëó÷àå, ê ãëóáîêîìó ñîæàëåíèþ ïðèìåíåíèå ëþáûõ ñõåì õèìèîòåðàïèè íå ïîçâîëÿåò äîáèòüñÿ ñêîëü ëèáî ñóùåñòâåííûõ ïîêàçàòåëåé âûæèâàåìîñòè. |
#3
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È âñå òàêè â èññëåäîâàíèÿ 3 ôàçû FOLFIRINOX ïðîòèâ ãåìöèòàáèíà ïîêàçàëè çíà÷èìîå óâåëè÷åíèå ñðåäíåãî âûæèâàíèÿ äî 11 ìåñ, ïî ñðàâíåíèþ ñ 6-8 ìåñ. Õîòÿ è ïîáî÷íûõ ýôôåêòîâ áûëî áîëüøå, êà÷åñòâî æèçíè, âðåìÿ áåç ïðîãðåññèðîâàíèÿ áûëè âûøå è íèæå óðîâåíü áîëè.
( Cunningham D, Chau I, Stocken DD, et al. Phase III randomized comparison of gemcitabine versus gemcitabine plus capecitabine in patients with advanced pancreatic cancer. J Clin Oncol 2009;27: 5513–18. Âîò òóò ðåêîìåíäóþò åãî âêëþ÷èòü FOLFIRINOX â ñòàíäàðòû êàê òåðàïèþ ïåðâîé ëèíèè. July 12, 2010 Submission Request c/o Joan McClure National Comprehensive Cancer Network 500 Old York Road, Suite 250 Jenkintown, PA 19046 RE: Updated Clinical Evidence in Support of Oxaliplatin in Pancreatic Cancer Name: Julia Petses, PharmD Company/Organization: sanofi-aventis Address: 55 Corporate Drive, Bridgewater, NJ 08807 Phone: (908) 981-7287 Email: [Ññûëêè äîñòóïíû òîëüêî çàðåãèñòðèðîâàííûì ïîëüçîâàòåëÿì ] Date of request: July 12, 2010 NCCN Guidelines Panel: Pancreatic Cancer Dear Ms. McClure, As the NCCN Pancreatic Cancer Panel reviews emerging evidence for this cancer type, on behalf of sanofi-aventis U.S., I respectfully request consideration of the inclusion of oxaliplatin in combination with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRINOX) as first-line treatment of metastatic pancreatic cancer. ["]Oxaliplatin in Combination with 5-fluorouracil, Leucovorin, and Irinotecan (FOLFIRINOX) as First-Line Therapy for Metastatic Pancreatic Cancer This request is for the NCCN Pancreatic Cancer Panel to review the FOLFIRINOX data from the phase III study by Conroy et al. 1 and to consider the addition of this regimen as first-line therapy for metastatic pancreatic cancer patients. FOLFIRINOX was compared with gemcitabine in 342 patients as first-line treatment of metastatic pancreatic cancer. 1 The primary endpoint was overall survival. A total of 250 patients were treated and evaluable for response. FOLFIRINOX demonstrated statistically significant greater overall survival (10.5 months vs 6.9 months, HR=0.61, P<0.001), progression free survival (6.4 months vs 3.4 months, P<0.0001), and response rate (27.6% vs 10.9%, P=0.0008) over treatment with gemcitabine. Grade 3/4 toxicities in FOLFIRINOX versus gemcitabine included diarrhea (12.3% vs 1.6%), nausea (15.6% vs 6.3%), vomiting (17.2% vs 6.3%), fatigue (24% vs 14.3%), neutropenia (47.9% vs 19.2%), and febrile neutropenia (5.7% vs 0). There were no toxic deaths. The authors concluded treatment with FOLFIRINOX resulted in significantly greater overall survival, progression free survival, and response rate than gemcitabine as first-line treatment of metastatic pancreatic cancer, with manageable toxicities. Specific changes recommended within the guidelines Please update the “Principles of Chemotherapy” (PANC-E) section to include FOLFIRINOX as a firstline treatment option for metastatic pancreatic cancer. FDA Status Oxaliplatin is not FDA-approved for use in patients with pancreatic cancer.Rationale for recommended change FOLFIRINOX is the first regimen that demonstrated significantly longer overall survival, progression free survival and response rate than gemcitabine alone. Literature support 1. Conroy T, Desseigne F, Ychou M, et al. Randomized phase lll trial comparing FOLFIRINOX (F: 5FU/leucovorin [LV], irinotecan [i], and oxaliplatin [O]) versus gemcitabine (G) as first-line treatment for metastatic pancreatic adenocarcinoma (MPA): Preplanned interim analysis results of the PRODIGE 4/ACCORD 11 trial [abstract]. J Clin Oncol ; 2010. 28(15S, pt 1);303s. Abs 4010. 2. Conroy T, Desseigne F, Ychou M, et al. Randomized phase lll trial comparing FOLFIRINOX (F: 5FU/leucovorin [LV], irinotecan [i], and oxaliplatin [O]) versus gemcitabine (G) as first-line treatment for metastatic pancreatic adenocarcinoma (MPA): Preplanned interim analysis results of the PRODIGE 4/ACCORD 11 trial [abstract]. Presented at the 46 th Annual Meeting of the American Society of Clinical Oncology, Chicago, Illinois, USA, June 4- 8, 2010. Abs4010. Available at: [Ññûëêè äîñòóïíû òîëüêî çàðåãèñòðèðîâàííûì ïîëüçîâàòåëÿì ] sessionID=340. Accessed July12, 2010. We appreciate the opportunity to provide this information for consideration by the NCCN Pancreatic Cancer Panel. If you have any questions or require additional information, please do not hesitate to contact me at (908) 981-7287 or via e-mail at [Ññûëêè äîñòóïíû òîëüêî çàðåãèñòðèðîâàííûì ïîëüçîâàòåëÿì ]. Thank you for your time and consideration. Sincerely, Julia Petses, PharmD Director, Oncology/Urology Medical Information Services sanofi-aventis U.S. Enclosures: Copies of referenced primary literature |
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[Ññûëêè äîñòóïíû òîëüêî çàðåãèñòðèðîâàííûì ïîëüçîâàòåëÿì ] |
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ß íèñêîëüêî íå ñîìíåâàþñü, ÷òî äàííàÿ ñõåìà ïîçâîëÿåò íåñêîëüêî óâåëè÷èòü ìåäèàíó âûæèâàåìîñòè, íåêîòîðûå èññëåäîâàíèÿ ïîêàçûâàþò ðàçíèöó â 3 ìåñÿöà, íåêîòîðûå 4, íî íå â ýòîì äåëî.
Ñî÷åòàíèå ïëàòèíû ñ èðèíîòåêàíîì ïîçâîëÿåò íåñêîëüêî óâåëè÷èòü ïîêàçàòåëè âûæèâàåìîñòè è ó áîëüíûõ ñ ðàêîì òîëñòîé êèøêè è ó áîëüíûõ ñ ðàêîì æåëóäêà, íî â ñòàíäàðòû îíà äî ñèõ ïîð íå âîøëà è, ñêîðåå âñåãî íå âîéäåò. Âî-ïåðâûõ, êàê ÿ óæå ïèñàë ñõåìà êðàéíå òîêñè÷íàÿ. Õîòÿ â âûâîäàõ íåêîòîðûõ èññëåäîâàíèé è ôèãóðèðóåò ÷òî-òî âðîäå "íåäîñòàòîê â âèäå òîêñè÷íîñòè ñõåìû êîìïåíñèðóåòñÿ ïðåèìóùåñòâàìè â ïîêàçàòåëÿõ âûæèâàåìîñòè", ÿ ñ ýòèì ñîãëàñèòñÿ íå ìîãó. Ñðàâíèòå àäåêâàòíîñòü ñîïðîâîäèòåëüíîé òåðàïèè íà çàïàäå, â êðóïíûõ îíêîëîãè÷åñêèõ öåíòðàõ Ðîññèè è íà ïåðèôåðèè. Âû óâåðåíû, ÷òî áóäåò äîñòàòî÷íîå êîëè÷åñòâî ÊÑÔ, áóäåò ñîáëþäàòüñÿ ðåæèì ââåäåíèÿ, áîëüíîé áóäåò íàõîäèòñÿ ïîä àäåêâàòíûì êîíòðîëåì è ïîëó÷èò ñâîåâðåìåííóþ ïîìîùü ïðè âîçíèêíîâåíèè òîêñè÷åñêîé ðåàêöèè? ß - íåò. Âî-âòîðûõ íåìàëîâàæåí ôèíàíñîâûé âîïðîñ.  ñòàíäàðòû ñõåìà íå âõîäèò è ïðåïàðàòû âåðîÿòíåå âñåãî ïðèäåòñÿ ïðèîáðåòàòü ñàìîñòîÿòåëüíî. Åñëè áû äåëî êàñàëîñü ìåíÿ, ÷åñòíî ãîâîðÿ, ÿ áû âåðîÿòíî âîîáùå îòêàçàëñÿ îò ïðîâåäåíèÿ õèìèîòåðàïèè â ïîäîáíîì ñëó÷àå.  öåëîì, åñëè åñòü ôèíàíñîâûå âîçìîæíîñòè, à òàê æå âîçìîæíîñòü îáåñïå÷èòü àäåêâàòíûé êîíòðîëü è ñîïðîâîäèòåëüíóþ òåðàïèþ - ñõåìó âïîëíå ìîæíî ïðèìåíÿòü, áëàãî äîêàçàòåëüíîé áàçû äëÿ îöåíêè ýôôåêòèâíîñòè âïîëíå äîñòàòî÷íî. Åñëè ñîáëþñòè óñëîâèÿ íåâîçìîæíî - òî íå ñòîèò è íà÷èíàòü. |
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ñïàñèáî.
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Àâòîð "Çåëåíîé ñòåíû" êàê ðàç ïî ýòîìó ïîâîäó êàê-òî ñêàçàë: Ñòèìîñòü ëå÷åíèÿ, îáåñïå÷èâàþùåãî óëó÷øåíèå âûæèâàåìîñòè ïðåâûøàåò 100 000, åñëè ÿ âäðóã çàáîëåþ, äàéòå ìíå 50, ÷òîáû ÿ ìîã ïðîæèòü ÒÀÊ ÊÀÊ ß ÇÀÕÎ×Ó è ÿ ñîãëàñåí ïðîæèòü íà 3 ìåñÿöà ìåíüøå....
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