Umeå University's logo

umu.sePublications
Change search
Link to record
Permanent link

Direct link
Andersson, Anne
Alternative names
Publications (10 of 30) Show all publications
Zhu, Y., Zerdes, I., Matikas, A., Cruz, I. R., Bergqvist, M., Elinder, E., . . . Foukakis, T. (2024). The role of serum thymidine kinase 1 activity in neoadjuvant-treated HER2-positive breast cancer: biomarker analysis from the swedish phase ii randomized predix HER2 trial. Breast Cancer Research and Treatment
Open this publication in new window or tab >>The role of serum thymidine kinase 1 activity in neoadjuvant-treated HER2-positive breast cancer: biomarker analysis from the swedish phase ii randomized predix HER2 trial
Show others...
2024 (English)In: Breast Cancer Research and Treatment, ISSN 0167-6806, E-ISSN 1573-7217Article in journal (Refereed) Epub ahead of print
Abstract [en]

Background: Thymidine kinase 1 (TK1) plays a pivotal role in DNA synthesis and cellular proliferation. TK1 has been studied as a prognostic marker and as an early indicator of treatment response in human epidermal growth factor 2 (HER2)-negative early and metastatic breast cancer (BC). However, the prognostic and predictive value of serial TK1 activity in HER2-positive BC remains unknown.

Methods: In the PREDIX HER2 trial, 197 HER2-positive BC patients were randomized to neoadjuvant trastuzumab, pertuzumab, and docetaxel (DPH) or trastuzumab emtansine (T-DM1), followed by surgery and adjuvant epirubicin and cyclophosphamide. Serum samples were prospectively collected from all participants at multiple timepoints: at baseline, after cycle 1, 2, 4, and 6, at end of adjuvant therapy, annually for a total period of 5 years and/or at the time of recurrence. The associations of sTK1 activity with baseline characteristics, pathologic complete response (pCR), event-free survival (EFS), and disease-free survival (DFS) were evaluated.

Results: No association was detected between baseline sTK1 levels and all the baseline clinicopathologic characteristics. An increase of TK1 activity from baseline to cycle 2 was seen in all cases. sTK1 level at baseline, after 2 and 4 cycles was not associated with pCR status. After a median follow-up of 58 months, 23 patients had EFS events. There was no significant effect between baseline or cycle 2 sTK1 activity and time to event. A non-significant trend was noted among patents with residual disease (non-pCR) and high sTK1 activity at the end of treatment visit, indicating a potentially worse long-term prognosis.

Conclusion: sTK1 activity increased following neoadjuvant therapy for HER2-positive BC but was not associated with patient outcomes or treatment benefit. However, the post-surgery prognostic value in patients that have not attained pCR warrants further investigation.

Trial registration: ClinicalTrials.gov, NCT02568839. Registered on 6 October 2015.

Place, publisher, year, edition, pages
Springer, 2024
Keywords
Biomarker, HER2 + breast cancer, Neoadjuvant treatment, Prognosis, Thymidine kinase
National Category
Cancer and Oncology
Identifiers
urn:nbn:se:umu:diva-219511 (URN)10.1007/s10549-023-07200-x (DOI)001135975300001 ()38175448 (PubMedID)2-s2.0-85181496134 (Scopus ID)
Funder
Swedish Cancer SocietySwedish Research CouncilThe Cancer Society in StockholmThe Breast Cancer FoundationSwedish Cancer Society, 21 0277 JCIA 01Region Stockholm, FoUI-977295Svensk onkologisk föreningIris, Stig och Gerry Castenbäcks Stiftelse för CancerforskningRegion StockholmSwedish Cancer SocietyThe Cancer Research Funds of RadiumhemmetSwedish Research CouncilKnut and Alice Wallenberg Foundation
Available from: 2024-01-22 Created: 2024-01-22 Last updated: 2024-01-22
Sund, M., Garmo, H., Andersson, A., Margolin, S., Ahlgren, J. & Valachis, A. (2023). Estrogen therapy after breast cancer diagnosis and breast cancer mortality risk. Breast Cancer Research and Treatment, 198(2), 361-368
Open this publication in new window or tab >>Estrogen therapy after breast cancer diagnosis and breast cancer mortality risk
Show others...
2023 (English)In: Breast Cancer Research and Treatment, ISSN 0167-6806, E-ISSN 1573-7217, Vol. 198, no 2, p. 361-368Article in journal (Refereed) Published
Abstract [en]

Purpose: The safety of local estrogen therapy in patients on adjuvant endocrine treatment is questioned, but evidence on the issue is scarce. This nested case–control registry-based study aimed to investigate whether estrogen therapy affects breast cancer mortality risk in women on adjuvant endocrine treatment.

Methods: In a cohort of 15,198 women diagnosed with early hormone receptor (HR)-positive breast cancer and adjuvant endocrine treatment, 1262 women died due to breast cancer and were identified as cases. Each case was matched with 10 controls. Exposure to estrogen therapy with concurrent use of aromatase inhibitors (AIs), tamoxifen, or both sequentially, was compared between cases and controls.

Results: No statistically significant difference in breast cancer mortality risk was seen in patients with exposure to estrogen therapy concurrent to endocrine treatment, neither in short-term or in long-term estrogen therapy use.

Conclusions: The study strengthens current evidence on local estrogen therapy use in breast cancer survivors, showing no increased risk for breast cancer mortality in patients on adjuvant AIs or tamoxifen.

Place, publisher, year, edition, pages
Springer Nature, 2023
Keywords
Breast cancer, Endocrine therapy, Estrogen therapy, Survivors
National Category
Cancer and Oncology
Identifiers
urn:nbn:se:umu:diva-205015 (URN)10.1007/s10549-023-06871-w (DOI)000932729800001 ()36773184 (PubMedID)2-s2.0-85147831911 (Scopus ID)
Funder
The Breast Cancer FoundationRegion Örebro County
Available from: 2023-02-21 Created: 2023-02-21 Last updated: 2023-07-12Bibliographically approved
Hughes, D. J., Schomburg, L., Jenab, M., Biessy, C., Méplan, C., Moskal, A., . . . Dossus, L. (2023). Prediagnostic selenium status, selenoprotein gene variants and association with breast cancer risk in a European cohort study. Free Radical Biology & Medicine, 209, 381-393
Open this publication in new window or tab >>Prediagnostic selenium status, selenoprotein gene variants and association with breast cancer risk in a European cohort study
Show others...
2023 (English)In: Free Radical Biology & Medicine, ISSN 0891-5849, E-ISSN 1873-4596, Vol. 209, p. 381-393Article in journal (Refereed) Published
Abstract [en]

Selenium (Se) may help prevent breast cancer (BC) development. Owing to limited observational evidence, we investigated whether prediagnostic Se status and/or variants in the selenoprotein genes are associated with BC risk in a large European cohort. Se status was assessed by plasma measures of Se and its major circulating proteins, selenoprotein P (SELENOP) and glutathione peroxidase 3 (GPX3), in matched BC case-control pairs (2208 for SELENOP; 1785 for GPX3 and Se) nested within the European Prospective Investigation into Cancer and Nutrition (EPIC). Single nucleotide polymorphisms (SNPs, n = 452) in 55 selenoprotein and Se metabolic pathway genes and an additional 18 variants previously associated with Se concentrations were extracted from existing genotyping data within EPIC for 1564 case-control pairs. Multivariable-adjusted logistic regression models were used to calculate the odds ratios (ORs) and 95 % confidence intervals (CIs) of the association between Se status markers, SNP variants and BC risk. Overall, there was no statistically significant association of Se status with BC risk. However, higher GPX3 activity was associated with lower risk of premenopausal BC (4th versus 1st quartile, OR = 0.54, 95 % CI: 0.30–0.98, Ptrend = 0.013). While none of the genetic variant associations (P ≤ 0.05) retained significance after multiple testing correction, rs1004243 in the SELENOM selenoprotein gene and two SNPs in the related antioxidant TXN2 gene (rs4821494 and rs5750261) were associated with respective lower and higher risks of BC at a significance threshold of P ≤ 0.01. Fourteen SNPs in twelve Se pathway genes (P ≤ 0.01) in interaction with Se status were also associated with BC risk. Higher Se status does not appear to be associated with BC risk, although activity of the selenoenzyme GPX3 may be inversely associated with premenopausal BC risk, and SNPs in the Se pathway alone or in combination with suboptimal Se status may influence BC risk.

Place, publisher, year, edition, pages
Elsevier, 2023
Keywords
Breast cancer risk, Gene-nutrient interaction, Glutathione peroxidase 3, Selenium status, Selenoprotein P
National Category
Nutrition and Dietetics Cancer and Oncology
Identifiers
urn:nbn:se:umu:diva-217407 (URN)10.1016/j.freeradbiomed.2023.10.401 (DOI)37923090 (PubMedID)2-s2.0-85176221883 (Scopus ID)
Funder
German Research Foundation (DFG), 849/6–2Swedish Cancer SocietySwedish Research CouncilRegion SkåneRegion Västerbotten
Available from: 2023-12-04 Created: 2023-12-04 Last updated: 2024-02-01Bibliographically approved
Sundén, M., Norgren, S., Lundqvist, R., Andersson, A., Sund, M. & Hemmingsson, O. (2023). Receptor conversion and survival in breast cancer liver metastases. Breast Cancer Research, 25(1), Article ID 105.
Open this publication in new window or tab >>Receptor conversion and survival in breast cancer liver metastases
Show others...
2023 (English)In: Breast Cancer Research, ISSN 1465-5411, E-ISSN 1465-542X, Vol. 25, no 1, article id 105Article in journal (Refereed) Published
Abstract [en]

Background: Breast cancer liver metastases (BCLM) is a common cause of breast cancer-related death. The prognostic and predictive value of receptor expression and St Gallen classification is challenged by receptor status discordance in distant metastases. The aim of this study was to determine the rate of receptor conversion from breast cancer to BCLM and the impact on survival.

Method: Patients registered with BCLM in two Swedish national cancer registers were recruited retrospectively. Data on receptor expression in primary breast cancer and BCLM were collected, as well as information about predictive factors for survival. The rate of receptor and subtype conversion was analyzed. A Cox regression model was used to investigate predictive factors for survival.

Results: A cohort of 132 patients with BCLM was identified. Estrogen receptor (ER), progesterone receptor (PgR) and HER2 converted in 17, 33 and 10%, respectively. PgR was lost in BCLM while 8/10 HER2 conversions went from negative to positive. The BC subtype was re-classified in 21% of the BCLM. Median survival after BCLM was 13 months and HER2 amplification was associated with improved survival (HR 0.28 CI 0.085–0.90). The highest predictive value (Harrell´s C-index) was obtained when including both BC and BCLM status.

Conclusions: Receptor and subtype conversions are common in BCLM, and a liver biopsy is warranted to tailor BCLM treatment. HER2 amplification is associated with improved survival in a BCLM cohort.

Place, publisher, year, edition, pages
BioMed Central (BMC), 2023
Keywords
Breast cancer, Estrogen receptor, Human epidermal growth factor receptor 2, Liver metastases, Progesterone receptor
National Category
Cancer and Oncology
Identifiers
urn:nbn:se:umu:diva-214618 (URN)10.1186/s13058-023-01706-4 (DOI)37705026 (PubMedID)2-s2.0-85171140754 (Scopus ID)
Funder
The Breast Cancer FoundationRegion VästerbottenNorrbotten County CouncilKnut and Alice Wallenberg FoundationSwedish Research Council
Available from: 2023-09-27 Created: 2023-09-27 Last updated: 2024-02-02Bibliographically approved
Andersson, A., Enblad, G., Erlanson, M., Johansson, A. S., Molin, D., Tavelin, B., . . . Melin, B. S. (2021). High risk of cardiovascular side effects after treatment of Hodgkin's lymphoma: is there a need for intervention in long-term survivors?. Upsala Journal of Medical Sciences, 126, Article ID e6117.
Open this publication in new window or tab >>High risk of cardiovascular side effects after treatment of Hodgkin's lymphoma: is there a need for intervention in long-term survivors?
Show others...
2021 (English)In: Upsala Journal of Medical Sciences, ISSN 0300-9734, E-ISSN 2000-1967, Vol. 126, article id e6117Article in journal (Refereed) Published
Abstract [en]

Background: Hodgkin lymphoma (HL) patients have a good prognosis after adequate treatment. Previous treatment with mantle field irradiation has been accompanied by an increased long-term risk of cardiovascular disease (CVD). This study identified co-morbidity factors for the development of cardiovascular side effects and initiated an intervention study aimed to decrease morbidity and mortality of CVD in HL survivors.

Design: Hodgkin lymphoma patients aged ≤45 years diagnosed between 1965 and 1995 were invited to participate. In total, 453 patients completed a questionnaire that addressed co-morbidity factors and clinical symptoms. Of these, 319 accepted to participate in a structured clinical visit. The statistical analyses compared individuals with CVD with those with no CVD.

Results: Cardiovascular disease was reported by 27.9%. Radiotherapy (odds ratio [OR]: 3.27), hypertension and hypercholesterolemia were shown to be independent risk factors for the development of CVD. The OR for CVD and valve disease in patients who received radiotherapy towards mediastinum was 4.48 and 6.07, respectively. At clinical visits, 42% of the patients were referred for further investigation and 24% of these had a cardiac ultrasound performed due to previously unknown heart murmurs.

Conclusion: Radiotherapy towards mediastinum was an independent risk factor for CVD as well as hypercholesterolemia and hypertension. A reasonable approach as intervention for this cohort of patients is regular monitoring of hypertension and hypercholesterolemia and referral to adequate investigation when cardiac symptoms appear. Broad knowledge about the side effects from radiotherapy in the medical community and well-structured information regarding late side effects to the patients are all reasonable approaches as late effects can occur even 40 years after cancer treatment.

Place, publisher, year, edition, pages
Upsala Medical Society, 2021
Keywords
cardiovascular side effects, Hodgkin lymphoma, intervention, survivorship
National Category
Cardiac and Cardiovascular Systems Cancer and Oncology
Identifiers
urn:nbn:se:umu:diva-184454 (URN)10.48101/ujms.v126.6117 (DOI)000683141500001 ()33889307 (PubMedID)2-s2.0-85107246635 (Scopus ID)
Available from: 2021-06-15 Created: 2021-06-15 Last updated: 2023-09-05Bibliographically approved
Hatschek, T., Foukakis, T., Bjöhle, J., Lekberg, T., Fredholm, H., Elinder, E., . . . Bergh, J. (2021). Neoadjuvant trastuzumab, pertuzumab, and docetaxel vs trastuzumab emtansine in patients with ERBB2-positive breast cancer. JAMA Oncology, 7(9), 1360-1367
Open this publication in new window or tab >>Neoadjuvant trastuzumab, pertuzumab, and docetaxel vs trastuzumab emtansine in patients with ERBB2-positive breast cancer
Show others...
2021 (English)In: JAMA Oncology, ISSN 2374-2437, E-ISSN 2374-2445, Vol. 7, no 9, p. 1360-1367Article in journal (Refereed) Published
Abstract [en]

Importance: Trastuzumab emtansine (T-DM1) is presently approved for treatment of advanced breast cancer and after incomplete response to neoadjuvant therapy, but the potential of T-DM1 as monotherapy is so far unknown.

Objective: To assess pathologic complete response (pCR) to standard neoadjuvant therapy of combination docetaxel, trastuzumab, and pertuzumab (DTP) vs T-DM1 monotherapy in patients with ERBB2 (formerly HER2)-positive breast cancer.

Design, Setting, and Participants: This randomized phase 2 trial, conducted at 9 sites in Sweden, enrolled 202 patients between December 1, 2014, and October 31, 2018. Participants were 18 years or older, with ERBB2-positive tumors larger than 20 mm and/or verified lymph node metastases. Analysis was performed on an intention-to-treat basis.

Interventions: Patients were randomized to receive 6 cycles of DTP (standard group) or T-DM1 (investigational group). Crossover was recommended at lack of response or occurrence of intolerable toxic effects. Assessment with fluorine 18–labeled fluorodeoxyglucose (18F-FDG) positron emission tomography combined with computed tomography (PET-CT) was performed at baseline and after 2 and 6 treatment cycles.

Main Outcome and Measures: Pathologic complete response, defined as ypT0 or Tis ypN0. Secondary end points were clinical and radiologic objective response; event-free survival, invasive disease-free survival, distant disease-free survival, and overall survival; safety; health-related quality of life (HRQoL); functional and biological tumor characteristics; and frequency of breast-conserving surgery.

Results: Overall, 202 patients were randomized; 197 (99 women in the standard group [median age, 51 years (range, 26-73 years)] and 98 women in the investigational group [median age, 53 years (range, 28-74 years)]) were evaluable for the primary end point. Pathologic complete response was achieved in 45 patients in the standard group (45.5%; 95% CI 35.4%-55.8%) and 43 patients in the investigational group (43.9%; 95% CI 33.9%-54.3%). The difference was not statistically significant (P = .82). In a subgroup analysis, the pCR rate was higher in hormone receptor–negative tumors than in hormone receptor–positive tumors in both treatment groups (45 of 72 [62.5%] vs 45 of 125 [36.0%]). Three patients in the T-DM1 group experienced progression during therapy. In an exploratory analysis, tumor-infiltrating lymphocytes at 10% or more (median) estimated pCR significantly (odds ratio, 2.76; 95% CI, 1.42-5.36; P = .003). Response evaluation with 18F-FDG PET-CT revealed a relative decrease of maximum standardized uptake value by equal to or greater than 68.7% (median) was associated with pCR (odds ratio, 6.74, 95% CI, 2.75-16.51; P < .001).

Conclusions and Relevance: In this study, treatment with standard neoadjuvant combination DTP was equal to T-DM1.

Trial Registrations: ClinicalTrials.gov Identifier: NCT02568839; EudraCT number: 2014-000808-10

Place, publisher, year, edition, pages
American Medical Association (AMA), 2021
National Category
Cancer and Oncology
Identifiers
urn:nbn:se:umu:diva-219400 (URN)10.1001/jamaoncol.2021.1932 (DOI)000666402600006 ()34165503 (PubMedID)2-s2.0-85108885363 (Scopus ID)
Available from: 2024-01-13 Created: 2024-01-13 Last updated: 2024-01-15Bibliographically approved
Sundén, M., Hermansson, C., Taflin, H., Andersson, A., Sund, M. & Hemmingsson, O. (2020). Surgical treatment of breast cancer liver metastases: A nationwide registry-based case control study. European Journal of Surgical Oncology, 46(6), 1006-1012
Open this publication in new window or tab >>Surgical treatment of breast cancer liver metastases: A nationwide registry-based case control study
Show others...
2020 (English)In: European Journal of Surgical Oncology, ISSN 0748-7983, E-ISSN 1532-2157, Vol. 46, no 6, p. 1006-1012Article in journal (Refereed) Published
Abstract [en]

Introduction: The benefit of liver resection or ablation for breast cancer liver metastases (BCLM) remains unclear. The aim of the study was to determine survival after isolated BCLM in nationwide cohorts and compare surgical versus systemic treatment regimens.

Materials and methods: The Swedish register for cancer in the liver and the bile ducts (SweLiv) and the National register for breast cancer (NBCR) was studied to identify patients with 1-5 BCLM without extrahepatic spread diagnosed 2009-2016. Data from the registers were validated and completed by review of medical records. A Kaplan-Meier plot and log rank test were used to analyse survival. Prognostic and predictive factors were evaluated by Cox regression analysis.

Results: A surgical cohort (n = 29) was identified and compared to a control cohort (n = 33) receiving systemic treatment only. There was no 90-day mortality after surgery. Median survival from BCLM diagnosis was 77 months (95% CI 41-113) in the surgical cohort and 28 months (95% CI 13-43) in the control cohort, (p = 0.004). There was a longer disease-free interval and more oestrogen receptor positive tumours in the surgical cohort. Surgery was a significant positive predictive factor in univariate analysis while a multivariable analysis resulted in HR 0.478 (CI 0.193-1.181, p = 0.110) for surgical treatment.

Conclusion: Surgery for BCLM is safe and might provide a survival benefit in selected patients but prospective trials are warranted to avoid selection bias.

Place, publisher, year, edition, pages
Elsevier, 2020
Keywords
Breast cancer, Liver metastases, Liver resection, Liver ablation
National Category
Surgery
Identifiers
urn:nbn:se:umu:diva-172505 (URN)10.1016/j.ejso.2020.02.008 (DOI)000537625100011 ()32098734 (PubMedID)2-s2.0-85079894172 (Scopus ID)
Available from: 2020-07-02 Created: 2020-07-02 Last updated: 2021-09-22Bibliographically approved
Andersson, A., von Wachenfeldt Väppling, A., de Jong, A. & Nyström, L. (2019). Adherence to adjuvant endocrine therapy after breast cancer in Sweden 2008-2010: a nationwide survey. In: : . Paper presented at Annual Meeting of the American-Society-of-Clinical-Oncology (ASCO), MAY 31-JUN 04, 2019, Chicago, IL (pp. 523-523). American Society of Clinical Oncology, 37(15)
Open this publication in new window or tab >>Adherence to adjuvant endocrine therapy after breast cancer in Sweden 2008-2010: a nationwide survey
2019 (English)Conference paper, Oral presentation with published abstract (Other academic)
Abstract [en]

Background: In estrogen receptor (ER) positive early breast cancer (EBC) adjuvant endocrine therapy (AET) is crucial to reduce recurrence and mortality. Previous studies have shown that adherence to AET is lower than expected and could negatively affect outcome. Since the year of 2000, BC patients in Sweden are treated in accordance to national guidelines. Treatment is offered at a low cost for the patient. The aim of the study was to estimate the adherence to AET in Sweden by regions and age groups. Methods: Women with a first primary EBC diagnosis 2008-2010 were identified through the Swedish Cancer Registry (SCR). Individual tumour and treatment data were retrieved from the Swedish National Breast Cancer Registry (SNBCR). Patients with ER negative tumours, small tumours (≤ 10 mm) and metastatic disease was excluded from the study since there were no indication to AET. Likewise, were individuals with AET registered to be administered by a third part excluded. Dispensed treatment from pharmacies was obtained through the Swedish Prescription Registry and medication possession rate (MPR) was calculated as number of dispensed doses divided by treatment duration in days. Good adherence to treatment in a patient was set at MPR ≥ 80 %. Adherence was calculated for 3 and 5 years. Results: Twenty-one thousand sixteen (21 016) individuals with a first primary BC between 2008 and 2010 was identified through SCR of which 20 596 were registered in the SNBCR. A total of 10 176 met the inclusion criteria in the study. Adherence after 3 years was 88.0 % and after 5 years 82.5 %. Adherence differed between regions in Sweden and was positively associated with age at diagnosis between 41-74 years. Urban areas had a lower adherence than rural areas (80.7 % vs 83.6 %; p= <0.001). Conclusions: Adherence to AET in Sweden was good, although there were differences by age and urban and rural areas. Further studies are needed to identify factors affecting differences in adherence, with the purpose of initiate actions to increase adherence to AET in ER positive EBC patients.

Place, publisher, year, edition, pages
American Society of Clinical Oncology, 2019
National Category
Cancer and Oncology
Identifiers
urn:nbn:se:umu:diva-164080 (URN)10.1200/JCO.2019.37.15_suppl.523 (DOI)000487345803516 ()
Conference
Annual Meeting of the American-Society-of-Clinical-Oncology (ASCO), MAY 31-JUN 04, 2019, Chicago, IL
Note

Supplement: S (May 20, 2019) 

Meeting Abstract: 523

Available from: 2019-10-14 Created: 2019-10-14 Last updated: 2020-01-17Bibliographically approved
Bergh, J. C. S., Andersson, A., Bjohle, J., Bosch, A., Carlsson, L., Dreifaldt, A. C., . . . Hatschek, T. (2019). Docetaxel, trastuzumab, pertuzumab versus trastuzumab emtansine as neoadjuvant treatment of HER2-positive breast cancer: results from the Swedish PREDIX HER2 trial identifying a new potential de-escalation standard?. Paper presented at Annual Meeting of the American-Society-of-Clinical-Oncology (ASCO), MAY 31-JUN 04, 2019, Chicago, IL. Journal of Clinical Oncology, 37(15), 501-501
Open this publication in new window or tab >>Docetaxel, trastuzumab, pertuzumab versus trastuzumab emtansine as neoadjuvant treatment of HER2-positive breast cancer: results from the Swedish PREDIX HER2 trial identifying a new potential de-escalation standard?
Show others...
2019 (English)In: Journal of Clinical Oncology, ISSN 0732-183X, E-ISSN 1527-7755, Vol. 37, no 15, p. 501-501Article in journal, Meeting abstract (Other academic) Published
Abstract [en]

Background: Neoadjuvant therapy produces high rates of pathological complete response (pCR) and is the standard of care in HER2 positive breast cancer; however, the optimal treatment regimen remains to be established. Methods: In this randomized phase II study patients ≥18 years with HER2 positive breast cancer > 20mm or verified lymph node metastases were randomized to 6 courses of docetaxel, trastuzumab and pertuzumab (DTP, group A) or trastuzumab emtansine (T-DM1, group B), q 21 days. The protocol allowed switch to the competing treatment upon lack of response or drug-related severe toxicity. Patients received postoperative epirubicin+cyclophosphamide, trastuzumab for a total of one year and endocrine therapy. Accrual was completed in October 2018 after randomization of 202 patients, data on pCR were available for 190 at the time for this abstract submission. Median age, 52 years (26-74), menopausal status, histological type and grade were well balanced between the treatment groups. 62.6% of the tumors were hormone receptor (HR) positive. Results: Primary endpoint was pathological objective response. 190 patients completed the protocol-specified preoperative treatment. pCR was achieved in 45.3% of patients, 46.4% in patients treated with DTP and 44.1% with T-DM1 (chi-sq., p = 0.75). In HR-positive tumors, pCR was obtained in 35.3% of patients, 35.9% in group A vs. 34.6% in group B (p = 0.87); in HR-negative tumors, the overall pCR rate was 62.0%, 66.7% in group A vs. 57.9% in group B (p = 0.45). Severe (grade 3/4) toxicity was reported at 68 occasions related to DTP, compared with 16 related to T-DM1, 26 vs. 3 caused by febrile neutropenia. Significantly better quality of life was reported by patients treated with T-DM1. Conclusions: Our data on TDM-1 demonstrates similar efficacy and less toxicity, in particular for patients with HER2 and HR positive cancers, being a potential new standard for neoadjuvant therapy. Clinical trial information: NCT02568839.

Place, publisher, year, edition, pages
American Society of Clinical Oncology, 2019
National Category
Cancer and Oncology
Identifiers
urn:nbn:se:umu:diva-164081 (URN)10.1200/JCO.2019.37.15_suppl.501 (DOI)000487345803494 ()
Conference
Annual Meeting of the American-Society-of-Clinical-Oncology (ASCO), MAY 31-JUN 04, 2019, Chicago, IL
Note

Supplement: S (May 20, 2019)

Meeting Abstract: 501

Available from: 2019-10-14 Created: 2019-10-14 Last updated: 2019-10-14Bibliographically approved
Brandberg, Y., Andersson, A., Bjohle, J., Bosch, A., Carlsson, L., Dreifaldt, A. C., . . . Hatschek, T. (2019). Health-related quality of life in the Swedish PREDIX HER2 trial, evaluating docetaxel, trastuzumab, pertuzumab versus trastuzumab emtansine as neoadjuvant treatment of HER2-positive breast cancer.. Paper presented at Annual Meeting of the American-Society-of-Clinical-Oncology (ASCO), MAY 31-JUN 04, 2019, Chicago, IL. Journal of Clinical Oncology, 37(15), 583-583
Open this publication in new window or tab >>Health-related quality of life in the Swedish PREDIX HER2 trial, evaluating docetaxel, trastuzumab, pertuzumab versus trastuzumab emtansine as neoadjuvant treatment of HER2-positive breast cancer.
Show others...
2019 (English)In: Journal of Clinical Oncology, ISSN 0732-183X, E-ISSN 1527-7755, Vol. 37, no 15, p. 583-583Article in journal, Meeting abstract (Other academic) Published
Abstract [en]

Background: Neoadjuvant therapy combining docetaxel, trastuzumab and pertuzumab (DTP) was compared to trastuzumab emtansine (T-DM1) in the randomized phase 2 PREDIX HER2 trial. Patients, ≥18 years with HER2 positive breast cancer, ≥20mm or with verified lymph node metastases, were randomized to six courses of DTP (Standard arm) or T-DM1 (Experimental arm). Primary endpoint was pathological objective response to primary medical therapy at post-treatment surgery. Health related quality of life (HRQoL) was a secondary outcome, and is of specific interest as there was no difference between the randomization groups regarding the main endpoint (results presented in a separate abstract sent to ASCO 2019, Bergh et al.). Methods: Of 202 randomized patients, 190 are available for evaluation at this point. HRQoL was measured, using EORTC QLQ-C30 + EORTC QLQ-BR23, at baseline before randomization and after six courses. Results: No differences between the randomization arms were found at baseline. Results after six courses, based on 163 patients (86%) and adjusted to baseline values, revealed statistical significant differences (p≤0.01), favoring the experimental T-DM1 arm on 7 out of 15 of the EORTC QLQ-C30 variables (Physical functioning, Role functioning, Social functioning, Global quality of Life, Fatigue, Dyspnea, and Diarrhea). For the breast cancer specific questionnaire (EORTC-BR23), the experimental arm scored statistically significantly better on 5 out of 7 subscales (Body image, Sexual functioning, Sexual enjoyment, Systemic therapy side effects and Upset by hair loss). All of the statistical significant differences were of moderate or large clinical significance (≥10 scale scores). No differences between the randomization arms were found for the remaining HRQoL variables. Conclusions: The experimental arm reported better HRQoL than the control arm after six courses. Trastuzumab emtansine may be a useful treatment alternative due to better HRQoL and lower toxicity. Clinical trial information: NCT02568839.

Place, publisher, year, edition, pages
American Society of Clinical Oncology, 2019
National Category
Cancer and Oncology
Identifiers
urn:nbn:se:umu:diva-164100 (URN)10.1200/JCO.2019.37.15_suppl.583 (DOI)000487345803574 ()
Conference
Annual Meeting of the American-Society-of-Clinical-Oncology (ASCO), MAY 31-JUN 04, 2019, Chicago, IL
Note

Supplement: S (May 20, 2019)

Meeting Abstract: 583

Available from: 2019-10-14 Created: 2019-10-14 Last updated: 2019-10-14Bibliographically approved
Organisations

Search in DiVA

Show all publications