natgillin/translations-raw huggingface dataset:
Neutraliserende anti-trastuzumab-antistoffer blev fundet i prøver efter baseline hos 2 ud af 30 patienter i armen behandlet med intravenøst Herceptin og hos 3 ud af 47 patienter i armen behandlet med subkutant Herceptin.
Neutralizing antitrastuzumab antibodies were detected in post-baseline samples in 2 of 30 patients in the Herceptin intravenous arm and 3 of 47 in the Herceptin subcutaneous arm. 21.0 % of patients treated with Herceptin subcutaneous formulation developed antibodies against the excipient hyaluronidase (rHuPH20).
Efter markedsføringen er der rapporteret om alvorlige pulmonale bivirkninger ved anvendelse af Herceptin (se pkt.
Severe pulmonary events have been reported with the use of Herceptin in the post-marketing setting (see section 4.8).
1Uregelmæssig hjerteslag
1 Heart beat irregular
En populationsfarmakokinetisk model med parallel lineær og ikke-lineær elimination fra det centrale kompartment blev konstrueret ved brug af samlede farmakokinetiske data fra Herceptin subkutan og Herceptin i.v.
A population PK model with parallel linear and nonlinear elimination from the central compartment was constructed using pooled Herceptin SC and Herceptin IV PK data from the phase III study BO22227 to describe the observed PK concentrations following Herceptin IV and Herceptin SC administration in EBC patients.
Ugentligt doseringsregime ved metastatisk brystkræft Effektresultaterne fra monoterapi og kombinationsterapi studierne er sammenfattet i tabel 3:
Weekly dosing in metatstatic breast cancer The efficacy results from the monotherapy and combination therapy studies are summarised in Table
Alvorlige infusionsrelaterede reaktioner, som er rapporteret efter infusion med Herceptin, omfatter dyspnø, hypotension, hvæsende vejrtrækning, hypertension, bronkospasmer, supraventrikulær takyarytmi, nedsat iltmætning, anafylaksi, åndedrætsbesvær, urticaria og angioødem (se pkt.
Serious IRRs to Herceptin infusion including dyspnoea, hypotension, wheezing, hypertension, bronchospasm, supraventricular tachyarrhythmia, reduced oxygen saturation, anaphylaxis, respiratory distress, urticaria and angioedema have been reported (see section 4.8).
Tabel 7: Endelig analyse af samlet overlevelse (OS) fra den samlede analyse af NSABP B-31- og NCCTG N9831-studierne
Table 7: Final Overall Survival Analysis from the joint analysis of trials NSABP B-31 and NCCTG N9831
Herceptin subkutan formulering er ikke beregnet til intravenøs administration og må kun administreres ved subkutan injektion.
Herceptin subcutaneous formulation is not intended for intravenous administration and should be administered via a subcutaneous injection only.
Instruktioner for aseptisk fortynding af den rekonstituerede opløsning: Beregn det nødvendige volumen af opløsningen:
Instructions for aseptic dilution of the reconstituted solution
Effektresultater fra MO16432 Parameter
Table 12 Efficacy Results from MO16432
Tabel 4: Effektresultater fra ikke-komparative studier med monoterapi- og kombinationsterapi Parameter
Table 4: Efficacy results from the non-comparative monotherapy and combination therapy studies Parameter
Hypertensive bivirkninger
Hypertensive events
Bivirkninger rapporteret med intravenøs Herceptin-monoterapi eller i kombination med kemoterapi i pivotale kliniske studier (N=8.386) samt efter markedsføring.
Table 1 Undesirable Effects Reported with Intravenous Herceptin Monotherapy or in Combination with Chemotherapy in Pivotal Clinical Trials (N = 8386) and in Post-Marketing
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Et hætteglas indeholder 600 mg trastuzumab/5 ml.
STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 600 mg/5 mL trastuzumab.
Median måneder
Duration of Response, Median months
Herceptin subkutan fast-dosis formulering er ikke beregnet til intravenøs brug og må kun gives som en subkutan injektion.
Herceptin subcutaneous fixed dose formulation is not for intravenous use and should be given as a subcutaneous injection only.
Herceptin intravenøs formulering er ikke beregnet til subkutan administration og må kun administreres ved intravenøs infusion.
Herceptin intravenous formulation is not intended for subcutaneous administration and should be administered via an intravenous infusion only.
LÆGEMIDLETS NAVN Herceptin 600 mg injektionsvæske, opløsning i hætteglas
NAME OF THE MEDICINAL PRODUCT Herceptin 600 mg solution for injection in vial
• Øvrige indholdsstoffer: L-histidinhydrochlorid monohydrat, L-histidin, α,α-trehalosedihydrat og polysorbat 20.
• The other ingredient(s) are L-histidine hydrochloride monohydrate, L-histidine, α,α-trehalose dihydrate, polysorbate 20.
Patienter med metastatisk brystkræft eller metastatisk ventrikelkræft bør behandles med Herceptin, indtil sygdommen progredierer.
Patients with MBC or MGC should be treated with Herceptin until progression of disease.
Hos patienter med en kropsvægt < 51 kg var trastuzumabs gennemsnitlige steady-state AUC omkring 80 % højere efter subkutan behandling sammenlignet med efter intravenøs behandling.
Due to the significant impact of body weight on trastuzumab clearance and the use of a fixed dose for the subcutaneous administration the difference in exposure between subcutaneous and intravenous administration was dependent on body weight: in patients with a body weight < 51 kg, mean steady state AUC of trastuzumab was about 80% higher after subcutaneous than after intravenous treatment whereas in the highest BW group (> 90 kg) AUC was 20% lower after subcutaneous than after intravenous treatment.
• betændelse i brystet
• inflammation of the breast
Herceptin intravenøs formulering er ikke beregnet til subkutan brug og må kun gives som en intravenøs infusion.
Herceptin intravenous formulation is not for subcutaneous use and should be given as an intravenous infusion only.
hos japanske kvinder med HER2-positiv metastisk brystkræft, tydede på, at samtidig administration af Herceptin ikke påvirkede docetaxels enkeltdosisfarmakokinetik.
weekly) and docetaxel (60 mg/m2 IV) in Japanese women with HER2- positive MBC, suggested that concomitant administration of Herceptin had no effect on the single dose pharmacokinetics of docetaxel.
Tabel 3: Effektresultater fra studier med monoterapi og kombinationsterapi Parameter
Table 3: Efficacy results from the monotherapy and combination therapy studies Parameter
Sjældne bivirkninger af Herceptin: kan forekomme hos op til 1 ud af 1.000 patienter
Rare side effects of Herceptin: may affect up to 1 in 1,000 people
• Opbevar lægemidlet utilgængeligt for børn
• Keep this medicine out of the sight and reach of children.
→ s.c. (s.c. hætteglas og s.c. formulering i injektionssystem, kohorter kombineret) var bivirkningsraterne (alle grader) før skiftet (serie 1-4) og efter skiftet (serie 5-8) henholdsvis 53,8 % versus 56,4 %.
For the sequence IV→SC (SC vial and SC formulation in administration system cohorts combined), adverse event rates (all grades) were described preswitching (Cycles 1-4) and post-switching (Cycles 5-8) as 53.8% vs. 56.4%, respectively; for the sequence SC→IV (SC vial and SC formulation in administration system cohorts combined), adverse event rates (all grades) were described pre- and post-switching as 65.4% vs. 48.7%, respectively.
- intravenøs paclitaxel - 80 mg/m2 som kontinuerlig intravenøs-infusion, administreret hver uge i 12 uger.
Paclitaxel, in combination with Herceptin, was administered as follows: - intravenous paclitaxel - 80 mg/m2 as a continuous intravenous infusion, given every week for 12 weeks.
Resultater for post-hoc eksplorativ analyse fra den samlede analyse fra de kliniske studier NSABP B-31/NCCTG N9831 og BCIRG006, hvor sygdomsfri overlevelse og symptomatiske kardielle bivirkninger blev kombineret
Table 11 Post-Hoc Exploratory Analysis Results from the Joint Analysis NSABP B-31/NCCTG N9831* and BCIRG006 Clinical Studies Combining DFS Events and Symptomatic Cardiac Events
Paclitaxel i kombination med Herceptin blev administreret som følger:
Docetaxel was administered as follows:
som blev efterfulgt af: - carboplatin - ved tilsigtet AUC = 6 mg/ml/min administreret som intravenøs infusion over 30-60 minutter gentaget hver 3. uge i samlet 6 serier.
weeks for 6 cycles (day 2 of cycle 1, then day 1 of each subsequent cycle) which was followed by: - carboplatin - at target AUC = 6 mg/mL/min administered by intravenous infusion over 3060 minutes repeated every 3 weeks for a total of six cycles
Tilbagefaldsfri overlevelse - Antal patienter med en hændelse - Antal patienter uden en hændelse p-værdi versus observation
Disease-free survival - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation Recurrence-free survival - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation
Patienter, som oplever hviledyspnø på grund af komplikationer fra avanceret malignitet og co-morbiditet, kan have forhøjet risiko for pulmonale hændelser.
Patients experiencing dyspnoea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of pulmonary events.
Tabel 16: Populationsforudsagte farmakokinetiske parameter værdier ved steady state for Herceptin i.v.-doseringsregimer hos patienter med metastatisk brystkræft, tidlig brystkræft og fremskreden ventrikelkræft.
Table 16 Population Predicted PK Parameter Values at Steady State for Herceptin IV Dosing
I et klinisk studie med patienter der havde metastatisk ventrikelkræft blev en vedligeholdelsesdosis på 10 mg/kg i 3-ugers intervaller efter en støddosis på 8 mg/kg undersøgt.
Single doses of Herceptin alone greater than 10 mg/kg have not been administered in the clinical trials; a maintenance dose of 10 mg/kg q3w following a loading dose of 8 mg/kg has been studied in a clinical trial with metastatic gastric cancer patients.
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Herceptin 600 mg injektionsvæske, opløsning i hætteglas Trastuzumab
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Herceptin 600 mg solution for injection
Sygdomsfri overlevelse - Antal patienter med en hændelse p < 0,0001
Disease-free survival No. patients with event p<0.0001
Herceptin og antracykliner bør ikke anvendes i kombination hos patienter, som får adjuverende behandling.
Herceptin and anthracyclines should not be given concurrently in combination in the adjuvant treatment setting.
5.2 Farmakokinetiske egenskaber.
Pharmacokinetic Properties.
De endelige resultater for samlet overlevelse fra den samlede analyse af NSABP B-31- og NCCTG N9831-studierne er opsummeret i tabel 7 nedenfor:
The final OS results from the joint analysis of studies NSABP B-31 and NCCTG N9831 are summarized in Table 7:
som efter operation blev efterfulgt af: - Yderligere serier af adjuverende Herceptin (indtil 1 års behandling var fuldført).
which was followed by - CMF on day 1 and 8 every 4 weeks for 3 cycles which was followed after surgery by - additional cycles of adjuvant Herceptin (to complete 1 year of treatment)
I BCIRG 006-studiet kan hazard ratioen for det primære endepunkt, sygdomsfri overlevelse, overføres til en absolut gavnlig effekt udtrykt i en 3-års sygdomsfri estimeret overlevelse på 5,8 procentpoint (86,7 % versus 80,9 %) til fordel for AC→DH (Herceptin)-armen og 4,6 procentpoint (85,5 % versus 80,9 %) til fordel for DCarbH (Herceptin)-armen sammenlignet med AC→D.
80.9 %) in favour of the AC→DH (Herceptin) arm and 4.6 percentage points (85.5 % versus 80.9 %) in favour of the DCarbH (Herceptin) arm compared to AC→D.
Effektresultaterne fra den samlede analyse af NSABP B-31 og NCCTG 9831-studierne efter den endelige analyse af sygdomsfri overlevelse* er sammenfattet i tabel 6.
The efficacy results from the joint analysis of the NSABP B-31 and NCCTG 9831 trials at the time of the definitive analysis of DFS* are summarized in Table 6.
Samlet overlevelse (død) - Antal patienter med en hændelse - Antal patienter uden en hændelse p-værdi versus observation
Overall survival (death) - No. patients with event - No. patients without event
Tidlig brystkræft 600 mg Herceptin subkutan 3-ugers doseringsregime
Herceptin SC 600 mg Q3W Dosing Regimen in EBC patients
Kardiel dysfunktion, administrationsrelaterede reaktioner, hæmatotoksicitet (specielt neutropeni) infektioner og pulmonale bivirkninger er til dato blandt de mest alvorlige og/eller almindelige bivirkninger rapporteret ved anvendelse af Herceptin (intravenøs og subkutan formuleringer).
Amongst the most serious and/or common adverse reactions reported in Herceptin usage (intravenous and subcutaneous formulations) to date are cardiac dysfunction, administration-related reactions, haematotoxicity (in particular neutropenia), infections and pulmonary adverse reactions.
Kardiel dysfunktion, infusionsrelaterede reaktioner, hæmatotoksicitet (specielt neutropeni), infektioner og pulmonale bivirkninger er til dato blandt de mest alvorlige og/eller almindelige bivirkninger rapporteret ved anvendelse af Herceptin (intravenøs og subkutan formulering).
Amongst the most serious and/or common adverse reactions reported in Herceptin usage (intravenous and subcutaneous formulations) to date are cardiac dysfunction, infusion-related reactions, haematotoxicity (in particular neutropenia), infections and pulmonary adverse reactions.
intravenøs bolus doxorubicin på 60 mg/m2, administreret hver 3. uge i 4 serier.
- intravenous push doxorubicin, at 60 mg/ m2, given every 3 weeks for 4 cycles.
Docetaxel blev administreret som følger: - intravenøs docetaxel - 100 mg/m2 som intravenøs infusion over 1 time, administreret hver
- intravenous docetaxel - 75 mg/m2 as an intravenous infusion over 1 hour, given every 3
Herceptin blev undersøgt som adjuverende behandling i 4 store multicenter, randomiserede studier: - Studie BO16348 var designet til at sammenligne 1 og 2-års Herceptin-behandling hver 3. uge versus observation hos patienter med HER2-positiv tidlig brystkræft efter operation, standardkemoterapi og strålebehandling (hvis indiceret).
- Study BO16348 was designed to compare one and two years of three-weekly Herceptin treatment versus observation in patients with HER2 positive EBC following surgery, established chemotherapy and radiotherapy (if applicable).
- intravenøs docetaxel - 75 mg/m2 som intravenøs infusion over 1 time, administreret hver 3. uge i 6 serier (dag 2 i serie 1, derefter dag 1 i hver af de efterfølgende serier)
- intravenous docetaxel - 100 mg/m2 as an intravenous infusion over 1 hour, given every 3 weeks for 4 cycles (day 2 of first docetaxel cycle, then day 1 of each subsequent cycle)
som efter operation blev efterfulgt af: • Yderligere serier af adjuverende Herceptin (indtil 1 års behandling var fuldført).
which was followed by • CMF on day 1 and 8 every 4 weeks for 3 cycles which was followed after surgery by • additional cycles of adjuvant Herceptin (to complete 1 year of treatment)
• lungeinfektioner
• throat infections
** Den mediane varighed af længerevarende opfølgning i den samlede analyse af de kliniske studier var 8,3 år (interval: 0,1-12,1) i AC→PH-armen og 7,9 år (interval: 0,0-12,2) i AC→P-armen.
Median duration of follow up was 1.8 years in the AC→P arm and 2.0 years in the AC→PH arm Median duration of long term follow-up for the Joint Analysis clinical studies was 8.3 years (range: 0.1 to 12.1) for the AC→PH arm and 7.9 years (range: 0.0 to 12.2) for the AC→P arm; Median duration of long term follow-up for the BCIRG 006 study was 10.3 years in both the AC→D arm (range: 0.0 to 12.6) arm and the
Desuden blev en post-hoc eksplorativ analyse udført på datasættene fra den samlede analyse fra studierne NSABP B-31/NCCTG N9831* og BCIRG 006, hvor sygdomsfri overlevelse og symptomatiske kardielle hændelser blev kombineret.
In addition a post-hoc exploratory analysis was performed on the data sets from the joint analysis (JA) NSABP B-31/NCCTG N9831* and BCIRG006 clinical studies combining DFS events and symptomatic cardiac events and summarised in Table 10: Table 10: Post-hoc exploratory analysis results from the joint analysis NSABP B-31/NCCTG N9831*
Almindelige bivirkninger af Herceptin: kan forekomme hos op til 1 ud af 10 patienter
Common side effects of Herceptin: may affect up to 1 in 10 people
Bivirkninger, som er blevet rapporteret i forbindelse med anvendelse af intravenøst Herceptin alene eller i kombination med kemoterapi i pivotale kliniske studier og efter markedsføringen, er præsenteret i tabel 1.
Presented in Table 1 are adverse reactions that have been reported in association with the use of intravenous Herceptin alone or in combination with chemotherapy in pivotal clinical trials and in the post-marketing setting.
Effektresultaterne fra den samlede analyse af NSABP B-31- og NCCTG N9831-studierne efter den endelige analyse af sygdomsfri overlevelse* er sammenfattet i tabel 7.
The efficacy results from the joint analysis of the NSABP B-31 and NCCTG 9831 trials at the time of the definitive analysis of DFS* are summarized in Table 7.
Responsvarighed
Adverse reaction
Der ses ingen farvning eller membranfarvning ses i < 10 % af tumorcellerne.
No staining is observed or membrane staining is observed in < 10 % of the tumour cells
* Ved median opfølgningstid, som var 1,8 år for patienterne i AC→P-armen og 2,0 år for patienterne i AC→PH
* At median duration of follow up of 1.8 years for the patients in the AC→P arm and 2.0 years for patients in the AC→PH arm ** p value for OS did not cross the pre-specified statistical boundary for comparison of AC→PH vs. AC→P
• gulsot • betændelse (betændelseslignende reaktion) eller arvæv i lungerne.
• inflammation or scarring of the lungs.
0,64; 95 % konfidensinterval = 0,55-0,74; log-rank p-værdi < 0,0001).
Treatment with AC→PH resulted in a statistically significant improvement in OS compared with AC→P (stratified HR=0.64; 95% CI [0.55, 0.74]; log-rank p-value < 0.0001).
Ikke almindelige bivirkninger af Herceptin: kan forekomme hos op til 1 ud af 100 patienter
Uncommon side effects of Herceptin: may affect up to 1 in 100 people
Forskel i patologisk fuldstændigt respons (subkutan- minus intravenøsarm)
Difference in pCR (SC minus IV arm)
og observerede serumkoncentrationer hos japanske kvinder med HER2-positiv metastatisk brystkræft (studie JP16003) blev der ikke fundet evidens for, at samtidig administration af docetaxel påvirkede trastuzumabs farmakokinetik.
By comparison of simulated serum trastuzumab concentrations after Herceptin monotherapy (4 mg/kg loading/2 mg/kg q1w IV) and observed serum concentrations in Japanese women with HER2- positive MBC (study JP16003) no evidence of a PK effect of concurrent administration of docetaxel on the pharmacokinetics of trastuzumab was found.
hvilket overføres til en absolut gavnlig effekt udtrykt i en 2-års sygdomsfri overlevelsesrate på 7,6 procentpoint (85,8 % versus 78,2 %) til fordel for Herceptin-armen.
The hazard ratio translates into an absolute benefit, in terms of 3-year disease-free survival rate estimates of 11.8 percentage points (87.2 % versus 75.4 %)
Tabel 9: Oversigt over effektanalyserne af AC→D versus DCarbH fra BCIRG 006-studiet
Table 10 Overview of Efficacy Analyses BCIRG 006 AC→D versus DCarbH Parameter
Død (OS hændelse) - Antal patienter med en hændelse p = 0,0182
No. patients with event p=0.0182
Derfor skal din hjertefunktion kontrolleres før, under (hver tredje måned) og efter behandlingen med Herceptin (op til to til fem år).
your heart function may be checked more frequently (every six to eight weeks), you may receive treatment for heart failure or you may have to stop Herceptin treatment.
3-ugers doseringsregime ved metastatisk brystkræft Effektresultaterne fra ikke-komparative monoterapi og kombinationsterapi studier er sammenfattet i tabel 5:
The efficacy results from the non-comparative monotherapy and combination therapy studies are summarised in Table 5:
Effektresultater fra ikke-komparative studier med monoterapi og kombinationsterapi Parameter
Table 5 Efficacy Results from the Non-Comparative Monotherapy and Combination Therapy Studies Parameter
- Studierne NSABP B-31- og NCCTG N9831, som udgør den samlede analyse, var designet til at undersøge den kliniske anvendelighed af at kombinere Herceptin-behandling med paclitaxel efter AC-kemoterapi.
- Studies NSABP B-31 and NCCTG N9831 that comprise the joint analysis were designed to investigate the clinical utility of combining Herceptin treatment with paclitaxel following AC chemotherapy, additionally the NCCTG N9831 study also investigated adding Herceptin sequentially to AC→P chemotherapy in patients with HER2 positive EBC following surgery.
Fremskreden ventrikelkræft 274 0,189-0,337
EBC 390 0.158 - 0.253 AGC 274 0.189 - 0.337
Anbefalet scoringssystem til evaluering af de IHC-farvede mønstre ved ventrikelkræft Score Kirurgisk prøve farvningsmønstre
The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 3: Table 3 Recommended Scoring System to Evaluate the IHC Staining Patterns in Gastric Cancer Score Surgical specimen - staining pattern
Patienter skal observeres for symptomer på administrationsrelaterede reaktioner i seks timer efter den første injektion og i to timer efter efterfølgende injektioner (se pkt.
Patients should be observed for six hours after the first injection and for two hours after subsequent injections for signs or symptoms of administration-related reactions (see sections 4.4 and 4.8).
• nakkesmerter
• nail disorders
3-ugers doseringsregime ved metastatisk brystkræft Effektresultaterne fra ikke-komparative monoterapi og kombinationsterapi studier er sammenfattet i tabel 4:
The efficacy results from the non-comparative monotherapy and combination therapy studies are summarised in Table 4:
Distant tilbagefald - Antal patienter med en hændelse p = 0,0008
No. patients with event p=0.0008
Død (OS hændelse) - Antal patienter med en hændelse p = 0,0024
No. patients with event p=0.0024
• den anden gives som en indsprøjtning under huden (subkutan injektion) Det er vigtigt at kontrollere præparatets etiket for at sikre, at der gives den korrekte formulering i henhold til ordinationen.
• the other is given as an injection under the skin (subcutaneous injection).
• gulsot • inflammation (betændelseslignende reaktion) eller arvæv i lungerne
• inflammation or scarring of the lungs
Svære bivirkninger af grad 3 blev rapporteret i henholdsvis 2,0 % og 1,7 % af patienterne under behandlingsfasen.
In the pivotal trial, the rate of all grade ARRs was 37.2 % with the Herceptin intravenous formulation and 47.8 % with the Herceptin subcutaneous formulation; severe grade 3 reactions were reported in 2.0 % and 1.7 % of the patients, respectively during the treatment phase; no severe grade 4 or 5 reactions were observed.
NSABP B-31- og NCCTG N9831-studierne, som udgør den samlede analyse, var designet til at undersøge den kliniske anvendelighed af at kombinere Herceptin-behandling med paclitaxel efter AC-kemoterapi.
- The NSABP B-31 and NCCTG N9831 studies that comprise the joint analysis were designed to investigate the clinical utility of combining Herceptin treatment with paclitaxel following AC chemotherapy, additionally the NCCTG N9831 study also investigated adding Herceptin sequentially to AC→P chemotherapy in patients with HER2 positive EBC following surgery.
[serie 5-8]).
(either 80 or 90).
- intravenøs docetaxel - 75 mg/m2 som intravenøs-infusion over 1 time, administreret hver 3. uge i 6 serier (dag 2 i serie 1, derefter dag 1 i hver af de efterfølgende serier)
- intravenous docetaxel - 75 mg/m2 as an intravenous infusion over 1 hour, given every 3 weeks for 6 cycles (day 2 of cycle 1, then day 1 of each subsequent cycle) which was followed by: - carboplatin - at target AUC = 6 mg/mL/min administered by intravenous infusion over 3060 minutes repeated every 3 weeks for a total of six cycles
Herceptin og antracykliner bør ikke anvendes samtidigt hos patienter, som får adjuverende behandling.
Herceptin and anthracyclines should not be given concurrently in the adjuvant treatment setting.
(n=1.679)
AC→P (n=1679)
Biopsi prøve - farvningsmønstre Vurdering af HER2overekspression
Biopsy specimenstaining pattern
Hazard ratio versus AC→P
Hazard Ratio vs
• kramper i benene
• skin rashes