natgillin/translations-raw huggingface dataset:
The recommended monotherapy dose of topotecan in patients with ovarian or small cell lung carcinoma and a creatinine clearance between 20 and 39 ml/ min is 0.75 mg/ m2 / day for 5 consecutive days.
Priporočeni odmerek topotekana kot samostojnega zdravila pri zdravljenju bolnic s karcinomom jajčnika in bolnikov z drobnoceličnim pljučnim karcinomom, ki imajo očistek kreatinina med 20 in 39 ml/ min je 0, 75 mg/ m2 na dan, 5 zaporednih dni.
Combination therapy (Cervical carcinoma) In clinical studies with topotecan in combination with cisplatin for the treatment of cervical cancer, therapy was only initiated in patients with serum creatinine less than or equal to 1.5 mg/ dL.
3 Kombinirano zdravljenje (karcinom materničnega vratu) Med kliničnimi študijami zdravljenja raka materničnega vratu je bilo zdravljenje s topotekanom v kombinaciji s cisplatinom uvedeno le pri bolnicah, ki so imele vrednost serumskega kreatinina manjšo ali enako 1, 5 mg/ dl.
If, during topotecan/ cisplatin combination therapy serum creatinine exceeds 1.5 mg/ dL, it is recommended that the full prescribing information be consulted for any advice on cisplatin dose reduction/ continuation.
Če med zdravljenjem s kombinacijo topotekan/ cisplatin vrednost serumskega kreatinina preseže 1, 5 mg/ dl, je priporočljivo pregledati navodila za predpisovanje cisplatina glede kakršnegakoli zmanjšanja odmerka cisplatina ali nadaljevanju zdravljenja.
3 Paediatrics The experience in children is limited, therefore no recommendation for treatment of paediatric patients with HYCAMTIN can be given (see sections 5.1 and 5.2).
Pediatrični bolniki Izkušnje pri otrocih so nezadostne, zato ni mogoče dati priporočil za zdravljenje pediatričnih bolnikov z zdravilom HYCAMTIN (glejte poglavji 5. 1 in 5. 2).
HYCAMTIN is contraindicated in patients who − have a history of severe hypersensitivity to the active substance or to any of the excipients − are breast feeding (see section 4.6) − already have severe bone marrow depression prior to starting first course, as evidenced by baseline neutrophils < 1.5 x 109/ l and/ or a platelet count of < 100 x 109/ l.
razvidno iz izhodiščnega števila nevtrofilcev < 1, 5 x 109/ l in/ ali števila trombocitov < 100 x 109/ l.
Haematological toxicity is dose-related and full blood count including platelets should be monitored regularly (see section 4.2).
Hematološka toksičnost je odvisna od odmerka, zato je treba bolnikom redno nadzorovati celotno krvno sliko, vključno s trombociti (glejte poglavje 4. 2).
Myelosuppression leading to sepsis and fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.8).
Pri bolnikih, ki so se zdravili s topotekanom, so poročali o mielosupresiji, ki je povzročila sepso in smrti zaradi sepse (glejte poglavje 4. 8).
Topotecan has been associated with reports of interstitial lung disease, some of which have been fatal (see section 4.8).
Med uporabo topotekana so bili opisani primeri intersticijske bolezni pljuč, nekateri s smrtnim izidom (glejte poglavje 4. 8).
Underlying risk factors include history of ILD, pulmonary fibrosis, lung cancer, thoracic exposure to radiation and use of pneumotoxic drugs and/ or colony stimulating factors.
Med osnovnimi dejavniki tveganja so anamneza intersticijske bolezni pljuč, pljučna fibroza, rak pljuč, izpostavljenost prsnega koša obsevanju in uporaba pnevmotoksičnih zdravil in/ ali kolonijo stimulirajočih faktorjev.
Patients should be monitored for pulmonary symptoms indicative of interstitial lung disease (e. g. cough, fever, dyspnoea and/ or hypoxia), and topotecan should be discontinued if a new diagnosis of ILD is confirmed.
Bolnike je treba kontrolirati glede pljučnih simptomov, ki kažejo na intersticijsko bolezen pljuč (npr. kašelj, zvišana telesna temperatura, dispneja in/ ali hipoksija); če je diagnoza intersticijske bolezni pljuč potrjena, je treba zdravljenje s topotekanom prekiniti.
Topotecan and topotecan in combination with cisplatin are commonly associated with clinically relevant thrombocytopenia.
Uporaba samega topotekana in topotekana v kombinaciji s cisplatinom je pogosto povezana s pojavom klinično pomembne trombocitopenije.
This should be taken into account, e. g. in case patients at increased risk of tumour bleeds are considered for therapy.
To je treba upoštevati, npr. pri bolnikih, pri katerih obstaja večje tveganje za pojav krvavitve tumorja.
As expected, patients with poor performance status (PS > 1) have a lower response rate and an increased incidence of complications such as fever, infection and sepsis (see section 4.8).
Kot je bilo pričakovati, se bolniki v slabšem telesnem stanju (PS > 1) slabše odzivajo na zdravilo in pri njih tudi pogosteje opažamo zaplete, kot so zvišana telesna temperatura, okužbe in sepsa (glejte poglavje 4. 8).
There is insufficient experience of the use of topotecan in patients with severely impaired renal function (creatinine clearance < 20 ml/ min) or severely impaired hepatic function (serum bilirubin ≥ 10 mg/ dl) due to cirrhosis.
Z uporabo topotekana za zdravljenje bolnikov s hudimi motnjami delovanja ledvic (očistek kreatinina < 20 ml/ min) ali s hudo okvaro jetrne funkcije, ki je posledica ciroze (serumski bilirubin ≥ 10 mg/ dl), nimamo dovolj izkušenj.
A small number of hepatically impaired patients (serum bilirubin between 1.5 and 10 mg/ dl) were given 1.5 mg/ m2 for five days every three weeks.
4 Le manjše število bolnikov z jetrno okvaro (vrednost serumskega bilirubina med 1, 5 in 10 mg/ dl) je prejelo odmerek 1, 5 mg/ m2 po 5 dni na vsake tri tedne.
A reduction in topotecan clearance was observed however there are insufficient data available to make a dose recommendation for this patient group.
Vseeno za sedaj nimamo na voljo zadostne količine podatkov, da bi priporočili odmerek za to skupino bolnikov.
Topotecan does not inhibit human P450 enzymes (see section 5.2).
Topotekan ne zavira encimov človeškega citokroma P450 (glejte poglavje 5. 2).
In a population study, the co- 4 administration of granisetron, ondansetron, morphine or corticosteroids did not appear to have a significant effect on the pharmacokinetics of total topotecan (active and inactive form).
V populacijski študiji niso zasledili, da bi sočasno dajanje granisetrona, ondansetrona, morfina ali kortikosteroidov pomembneje vplivalo na farmakokinetiko celokupnega topotekana (aktivne in neaktivne oblike).
When topotecan (0.75 mg/ m2/ day for 5 consecutive days) and cisplatin (60 mg/ m2/ day on Day 1) were administered in 13 patients with ovarian cancer, a slight increase in AUC (12%, n=9) and Cmax (23%, n=11) was noted on day 5.
Pri dajanju topotekana (0, 75 mg/ m2/ dan 5 zaporednih dni) in cisplatina (60 mg/ m2/ dan na 1. dan) 13 bolnicam z rakom jajčnika so 5. dan opazili rahlo povečanje vrednosti AUC (12%, n = 9) in Cmax (23%, n = 11).
Topotecan has been shown to cause embryo-foetal lethality and malformations in preclinical studies (see section 5.3).
Predklinične raziskave so pokazale, da topotekan povzroča smrt in deformacije zarodka oziroma ploda (glejte poglavje 5. 3).
Topotecan is contra-indicated during breast-feeding (see section 4.3).
Topotekan je med dojenjem kontraindiciran (glejte poglavje 4. 3).
No effects on male or female fertility have been observed in reproductive toxicity studies in rats (see section 5.3).
V študijah vpliva na sposobnost razmnoževanja pri podganah niso ugotovili učinkov na plodnost samcev ali samic (glejte poglavje 5. 3).
The adverse event profile for topotecan when given in combination with cisplatin in the cervical cancer clinical trials is consistent with that seen with topotecan monotherapy.
5 Pri kombiniranem zdravljenju raka materničnega vratu s cisplatinom med kliničnimi preskušanji so bili neželeni učinki topotekana enaki kot pri samostojnem zdravljenju s topotekanom.
5 The integrated safety data for topotecan monotherapy are presented below.
V nadaljevanju navajamo povzetek podatkov o varnosti topotekana kot samostojnega zdravila.
Frequencies are defined as: very common (≥ 1/ 10), common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000), including isolated reports and not known (cannot be estimated from the available data).
Pogostnost je definirana z izrazi: zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100, < 1/ 10), občasni (≥ 1/ 1. 000, < 1/ 100), redki (≥ 1/ 10. 000, < 1/ 1. 000) in zelo redki (< 1/ 10. 000), vključno s posameznimi primeri in ni znano (ni mogoče oceniti na podlagi podatkov, ki so na voljo).
Blood and lymphatic system disorders Very common: febrile neutropenia, neutropenia (see Gastrointestinal disorders), thrombocytopenia, anaemia, leucopenia.
Bolezni krvi in limfatičnega sistema Zelo pogosti: nevtropenija s sočasno povišano telesno temperaturo, nevtropenija (glejte Bolezni prebavil), trombocitopenija, anemija, levkopenija
Respiratory, thoracic and mediastinal disorders Rare: interstitial lung disease
Bolezni dihal, prsnega koša in mediastinalnega prostora Redki: intersticijska bolezen pljuč
Nausea, vomiting and diarrhoea (all of which may be severe), constipation, abdominal pain* and mucositis. *Neutropenic colitis, including fatal neutropenic colitis, has been reported to occur as a complication of topotecan-induced neutropenia (see section 4.4).
Bolezni prebavil Zelo pogosti: navzea, bruhanje in driska (vse lahko hudo), zaprtje, abdominalna bolečina * in mukozitis * Poročali so o pojavu nevtropeničnega kolitisa, vključno z usodnim nevtropeničnim kolitisom, kot zapletu s topotekanom povzročene nevtropenije (glejte poglavje 4. 4).
Common: pruritus.
Bolezni kože in podkožja Zelo pogosti: alopecija Pogosti: pruritus
Metabolism and nutrition disorders Very common: anorexia (which may be severe).
Presnovne in prehranske motnje Zelo pogosti: anoreksija (ki je lahko huda)
Infections and infestations Very common: infection Common: sepsis
Infekcijske in parazitske bolezni Zelo pogosti: okužba Pogosti: sepsa
Very rare: extravasation*. *Extravasation has been reported very rarely.
Splošne težave in spremembe na mestu aplikacije Zelo pogosti: pireksija, astenija, utrujenost Pogosti: splošno slabo počutje Zelo redki: ekstravazacija * * O ekstravazaciji so poročali zelo redko.
Immune system disorders Common: hypersensitivity reaction including rash Rare: anaphylactic reaction, angioedema, urticaria.
Bolezni imunskega sistema Pogosti: preobčutljivostna reakcija, vključno z izpuščajem Redki: anafilaktična reakcija, angioedem, urtikarija
Hepato-biliary disorders Common: hyperbilirubinaemia.
6 Bolezni jeter, žolčnika in žolčevodov Pogosti: hiperbilirubinemija
The incidence of adverse events listed above have the potential to occur with a higher frequency in patients who have a poor performance status (see section 4.4).
Pojavnost zgoraj navedenih neželenih dogodkov je lahko pogostejša pri bolnikih s slabšim telesnim stanjem (glejte poglavje 4. 4).
The frequencies associated with the haematological and non-haematological adverse events listed below represent the adverse event reports considered to be related/ possibly related to topotecan therapy.
V nadaljevanju navedena pogostnost hematoloških in nehematoloških neželenih dogodkov se nanaša na poročila o neželenih dogodkih, ki so bili ali bi lahko bili povezani z zdravljenjem s topotekanom.
6 Haematological Neutropenia:
Hematološki Nevtropenija:
Severe (neutrophil count < 0.5 x 109/ l) during course 1 was seen in 55% of the patients and with duration ≥ 7 days in 20% and overall in 77% of patients (39% of courses).
Med prvim ciklom zdravljenja je imelo 55% bolnikov hudo obliko nevtropenije (število nevtrofilcev < 0, 5 x 109/ l), ki je pri 20% bolnikov trajala ≥ 7 dni, pri 77% pa ves čas (39% ciklov zdravljenja).
In association with severe neutropenia, fever or infection occurred in 16% of patients during course 1 and overall in 23% of patients (6% of courses).
Ob hudi nevtropeniji so med prvim ciklom zdravljenja pri 16% bolnikov opazili zvišano telesno temperaturo ali različne okužbe, 23% bolnikov pa je imelo takšne neželene učinke ves čas (6% ciklov zdravljenja).
Median time to onset of severe neutropenia was 9 days and the median duration was 7 days.
Mediana časa do začetka hude nevtropenije je bila 9 dni, mediana trajanja nevtropenije pa 7 dni.
Severe neutropenia lasted beyond 7 days in 11% of courses overall.
Huda nevtropenija je pri 11% vseh ciklov zdravljenja trajala več kot 7 dni.
Among all patients treated in clinical trials (including both those with severe neutropenia and those who did not develop severe neutropenia), 11% (4% of courses) developed fever and 26% (9% of courses) developed infection.
11% vseh bolnikov (4% ciklov zdravljenja), ki so se zdravili v kliničnih raziskavah (vključno z bolniki s hudo nevtropenijo in s tistimi, pri katerih se nevtropenija ni pojavila), je imelo zvišano telesno temperaturo, pri 26% (9% ciklov zdravljenja) pa so se pojavile okužbe.
In addition, 5% of all patients treated (1% of courses) developed sepsis (see section 4.4).
Poleg tega je pri 5% vseh zdravljenih bolnikov (1% ciklov zdravljenja) prišlo do sepse (glejte poglavje 4. 4).
Severe (platelets less than 25 x 109/ l) in 25% of patients (8% of courses); moderate (platelets between 25.0 and 50.0 x 109/ l) in 25% of patients (15% of courses).
Huda oblika (število trombocitov manjše od 25 x 109/ l) pri 25% bolnikov (8% ciklov zdravljenja); zmerna (število trombocitov med 25, 0 in 50, 0 x 109/ l) pa pri 25% bolnikov (15% ciklov zdravljenja).
Median time to onset of severe thrombocytopenia was Day 15 and the median duration was 5 days.
Mediana časa do pojava hude trombocitopenije je bila 15. dan, mediana trajanja trombocitopenije pa 5 dni.
Platelet transfusions were given in 4% of courses.
V 4% ciklov zdravljenja so bile uporabljene transfuzije trombocitov.
Moderate to severe (Hb ≤ 8.0 g/ dl) in 37% of patients (14% of courses).
Zmerna do huda (Hb ≤ 8, 0 g/ dl) pri 37% bolnikov (14% ciklov zdravljenja).
Red cell transfusions were given in 52% of patients (21% of courses).
52% bolnikov je prejelo transfuzijo eritrocitov (21% ciklov zdravljenja).
Non-haematological Frequently reported non-haematological effects were gastrointestinal such as nausea (52%), vomiting (32%), and diarrhoea (18%), constipation (9%) and mucositis (15%).
Nehematološki Pogostejši nehematološki učinki so bile gastrointestinalne težave, kot so navzea (52%), bruhanje (32%), driska (18%), zaprtje (9%) in mukozitis (15%).
Severe (grade 3 or 4) nausea, vomiting, diarrhoea and mucositis incidence was 4, 3, 2 and 1% respectively.
Hude oblike (3. ali 4. stopnje) motenj so ugotavljali v naslednjih odstotkih: navzea 4%, bruhanje 3%, driska 2%, mukozitis 1%.
Mild abdominal pain was also reported amongst 4% of patients.
4% bolnikov je imelo blage bolečine v trebuhu.
Fatigue was observed in approximately 25% and asthenia in 16% of patients whilst receiving topotecan.
Med zdravljenjem s topotekanom so pri približno 25% bolnikov opazili utrujenost, pri 16% pa astenijo.
Severe (grade 3 or 4) fatigue and asthenia incidence was 3 and 3% respectively.
Pojavnost tako hude oblike utrujenosti kot astenije (3. ali 4. stopnje) je bila 3%.
Total or pronounced alopecia was observed in 30% of patients and partial alopecia in 15% of patients.
Popolna ali izrazita alopecija se je pojavila pri 30% bolnikov, delna pa pri 15% bolnikov.
Other severe events occurring in patients that were recorded as related or possibly related to topotecan treatment were anorexia (12%), malaise (3%) and hyperbilirubinaemia (1%).
Drugi hujši učinki, ki so se pojavili pri bolnikih in so jih ocenili kot posledico ali možno posledico zdravljenja s topotekanom, so bili anoreksija (12%), občutek slabosti (3%) in hiperbilirubinemija (1%).
In clinical trials, rash was reported in 4% of patients and pruritus in 1.5% of patients.
Med kliničnimi preskušanji so o izpuščaju poročali pri 4% bolnikov in o pruritusu pri 1, 5% bolnikov.
ATC code:
Druga zdravila z delovanjem na novotvorbe (citostatiki), oznaka ATC:
7 The anti-tumour activity of topotecan involves the inhibition of topoisomerase-I, an enzyme intimately involved in DNA replication as it relieves the torsional strain introduced ahead of the moving replication fork.
Protitumorsko delovanje topotekana vključuje zaviranje encima topoizomeraze I, tesno povezanega s podvojevanjem DNA, saj sprošča torzijsko napetost, ki nastopa pred napredujočimi replikacijskimi vilicami.
In a comparative study of topotecan and paclitaxel in patients previously treated for ovarian carcinoma with platinum based chemotherapy (n = 112 and 114, respectively), the response rate (95% CI) was 20.5% (13%, 28%) versus 14% (8%, 20%) and median time to progression 19 weeks versus 15 weeks (hazard ratio 0.7 [0.6, 1.0]), for topotecan and paclitaxel, respectively.
Stopnja odzivnosti na zdravljenje (95% interval zaupanja) je znašala 20, 5% (13%, 28%) oziroma 14% (8%, 20%), mediana časa napredovanja pa 19 tednov za topotekan in 15 tednov za paklitaksel (razmerje tveganja 0, 7 [0, 6, 1, 0]).
Median overall survival was 62 weeks for topotecan versus 53 weeks for paclitaxel (hazard ratio 0.9 [0.6, 1.3]).
Mediana časa preživetja je bila 62 tednov pri uporabi topotekana in 53 tednov pri zdravljenju s paklitakselom (razmerje tveganja 0, 9 [0, 6, 1, 3]).
The response rate in the whole ovarian carcinoma programme (n = 392, all previously treated with cisplatin or cisplatin and paclitaxel) was 16%.
Odzivnost na zdravilo za celoten program raziskav raka na jajčnikih (n = 392, pri bolnicah, ki so se pred tem zdravile s cisplatinom ali cisplatinom in paklitakselom) je bila 16%.
The median time to response in clinical trials was 7.6- 11.6 weeks.
Srednji odzivni čas je v kliničnih raziskavah znašal od 7, 6 do 11, 6 tednov.
In patients refractory to, or relapsing within 3 months after cisplatin therapy (n = 186), the response rate was 10%.
Pri bolnicah, ki se jim je bolezen kljub zdravljenju s cisplatinom ponovila v roku 3 mesecev, ali ki se niso odzvale na zdravilo (n = 186), pa je bila odzivnost 10%.
These data should be evaluated in the context of the overall safety profile of the medicinal product, in particular to the important haematological toxicity (see section 4.8).
Pri vrednotenju teh podatkov je treba upoštevati vsa dejstva o varnosti zdravila; hematološka toksičnost je še posebej pomembna (glejte poglavje 4. 8).
For patients administered more than 6 cycles of therapy, 91% completed the study as planned or were treated until disease progression with only 3% withdrawn for adverse events.
Od bolnic, ki so bile deležne več kot 6 ciklov zdravljenja, jih je 91% dokončalo raziskavo kot je bilo predvideno, ali pa so jih zdravili, dokler je bila bolezen v progresiji.
A phase III trial compared oral topotecan plus Best Supportive Care [BSC] [n=71] with BSC alone [n=70] in patients who had relapsed following first line therapy [median time to progression [TTP] from first-line therapy:
Raziskava je bila opravljena pri bolnikih, pri katerih je po zdravljenju s terapijo prve izbire prišlo do relapsa [srednji čas do progresije, ki je minil od zdravljenja s terapijo prve izbire:
84 days for oral topotecan + BSC, 90 days for BSC] and for whom retreatment with i. v chemotherapy was not considered appropriate.
84 dni za zdravljenje s peroralnim topotekanom v kombinaciji z NPO; 90 dni za zdravljenje z NPO samo] in pri katerih zdravljenje z intravensko obliko kemoterapije ni bilo primerno.
Oral topotecan plus BSC group had a statistically significant improvement in overall survival compared with the BSC alone group (Log- rank p=0.0104).
Celotno preživetje v skupini, ki je dobivala peroralni topotekan in NPO, je bilo statistično značilno boljše kot v skupni, ki je bila deležna le NPO (vrednost p za log- rang = 0, 0104).
The unadjusted hazard ratio for oral topotecan plus BSC group relative to BSC alone group was 0.64 (95% CI:
Nekorigirano razmerje tveganja med skupino s peroralnim topotekanom in NPO ter skupino s samo NPO je bilo 0, 64 (95% IZ:
11.1, 18.6] for patients receiving BSC alone [p=0.0104].
Srednji čas preživetja bolnikov, ki so bili zdravljeni s peroralnim topotekanom v kombinaciji z NPO je bil 25, 9 tednov [95% interval zaupanja 18, 3; 31, 6] pri bolnikih, ki so bili zdravljeni z NPO samo pa 13, 9 tednov [95% interval zaupanja 11, 1; 18, 6] [p=0. 0104].
One Phase 2 study (Study 065) and one Phase 3 study (Study 396) were conducted to evaluate the efficacy of oral topotecan versus intravenous topotecan in patients who had relapsed ≥ 90 days after completion of one prior regimen of chemotherapy. (see Table 1).
8 Za oceno učinkovitosti peroralnega topotekana v primerjavi z intravenskim topotekanom pri bolnikih, ki se jim je pojavil relaps ≥ 90 dni po koncu ene predhodne sheme kemoterapije, sta bili narejeni ena študija 2. faze (študija 065) in ena študija 3. faze (študija 396) (glejte tabelo 1).
8 Table 1.
Tabela 1.
Oral topotecan
(26, 3, 40, 9)
Intravenous Oral topotecan topotecan
(21, 1, 33, 0)
Intravenous topotecan
(29, 1, 42, 4)
(N = 52)
(31, 0, 37, 1)
(N = 54) (N = 153)
0, 88 (0, 59, 1, 31)
(N = 151)
0, 88 (0, 7, 1, 11)
Median survival (weeks) (95% CI) Hazard ratio (95% CI) Response rate (%) (95% CI)
Delež odziva (%)
32.3 (26.3, 40.9) 0.88 (0.59, 23.1 (11.6, 34.5)
(11, 6, 34, 5)
25.1 33.0 (21.1, 33.0) (29.1, 42.4) 1.31) 0.88 (0.7, 14.8 18.3 (5.3, 24.3) (12.2, 24.4)
(12, 2, 24, 4)
Difference in response rate (95% CI)
Razlika v deležu odziva (95% IZ)
Hazard ratio (95% CI) total number of patients treated.
Razmerje tveganja (95% IZ) n = celotno število zdravljenih bolnikov IZ = interval zaupanja
In another randomised phase III trial which compared IV topotecan to cyclophosphamide, Adriamycin (doxorubicin) and vincristine (CAV) in patients with relapsed, sensitive SCLC, the overall response rate was 24.3% for topotecan compared to 18.3% for the CAV group.
Pri bolnikih z relapsom dovzetnega drobnoceličnega pljučnega raka je bil celoten odstotek odziva na topotekan 24, 3%, na kombinacijo CAV pa 18, 3%.
Median time to progression was similar in the two groups (13.3 weeks and 12.3 weeks respectively).
Srednji čas do progresije je bil v obeh skupinah podoben, in sicer pri topotekanu 13, 3 tedna, pri kombinaciji CAV pa 12, 3 tedna.
Median survivals for the two groups were 25.0 and 24.7 weeks respectively.
Srednji čas preživetja bolnikov v skupini, ki je prejemala topotekan je bil 25, 0 tednov, v skupini, ki je prejemala kombinacijo CAV pa 24, 7 tedna.
The hazard ratio for survival of IV topotecan relative to CAV was 1.04 (95% CI 0.78 – 1.40).
0, 78 – 1, 40).
The response rate to topotecan in the combined small cell lung cancer programme [n = 480] for patients with relapsed disease sensitive to first-line therapy, was 20.2%.
Odstotek odziva na topotekan pri kombiniranem režimu zdravljenja drobnoceličnega pljučnega raka [n = 480] pri bolnikih z relapsom bolezni, dovzetne na zdravljenje s terapijo prve izbire je bil 20, 2%.
The median survival was 30.3 weeks (95% CI:
Srednji čas preživetja je bil 30, 3 tednov (95% interval zaupanja:
In a population of patients with refractory SCLC (those not responding to first line therapy), the response rate to topotecan was 4.0%.
V skupini bolnikov z neodzivnim drobnoceličnim pljučnim rakom (obliko, ki se ne odziva na zdravljenje s terapijo prve izbire) je bil odziv na topotekan 4, 0- odstoten.
In a randomised, comparative phase III trial conducted by the Gynaecological Oncology Group (GOG 0179), topotecan plus cisplatin (n=147) was compared with cisplatin alone (n=146) for the treatment of histologically confirmed persistent, recurrent or Stage IVB carcinoma of the cervix where curative treatment with surgery and/ or radiation was not considered appropriate.
Pri vmesni analizi je imela kombinacija topotekana in cisplatina statistično
Topotecan plus cisplatin had a statistically significant benefit in overall survival relative to cisplatin monotherapy after adjusting for interim analyses (Log-rank p =0.033).
9 pomembno korist na skupno preživetje v primerjavi z zdravljenjem s samim cisplatinom (log- rank p = 0, 033).
9 Study results Study GOG-0179
Rezultati študije GOG- 0179
Cisplatin
cisplatin
1 q21 d.
50 mg/ m2 1. dan na 21 dni
50mg/ m2 d.
50 mg/ m2 1. dan + topotekan
1 + Topotecan 0.75mg/ m2 dx3 q21
0, 75 mg/ m2/ dan x 3 na 21 dni
Survival (months) Median (95% C. I.)
Preživetje (meseci)