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  • 1
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 34, No. 15_suppl ( 2016-05-20), p. TPS9108-TPS9108
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2016
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  • 2
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 36, No. 15_suppl ( 2018-05-20), p. e21236-e21236
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2018
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  • 3
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 81, No. 4_Supplement ( 2021-02-15), p. PS11-16-PS11-16
    Abstract: Introduction Invasive lobular breast cancer (ILC) is with 5-10% the second most common histologic type of invasive breast cancer after invasive ductal breast cancer (IDC). ILC differs from IDC, for example in its metastatic pattern. However, guidelines do not provide special treatment recommendations for this subtype and specific clinical studies are rare. Here we present prospective data on characteristics, treatment and outcome of patients (pts) with advanced ILC in routine care in Germany. Methods The Tumor Registry Breast Cancer (TMK) has prospectively documented data of pts with breast cancer by oncologists in Germany since 2007. Since 2017 OPAL continues the TMK work with representation of all specialists (medical and gynecologic oncologists) treating advanced breast cancer (ABC). Both projects are prospective, observational, open, longitudinal multicenter cohort studies (clinical registries). Pts at the start of their treatment can be included after signing informed consent. Together over 7500 pts (4250 with ABC) will be recruited from over 150 sites in Germany. There is no treatment specification. Details on all (sequential) treatments, patient and tumor characteristics, clinical and patient-reported outcomes are documented. Follow-Up is until death or up to 5 years. Here, data as of March, 31st 2020 are presented. Results Pts with advanced ILC (n=372) were older at start of first-line treatment (median 68 vs. 63 years) while ECOG performance status (ECOG 0 25% vs 29%) and Charlson Comorbidity Index (CCI 0: 82% vs 84%) were similar compared to pts with IDC (n=1745). The lobular tumor was more often hormone receptor (HR) positive (87% vs 74%) and less often HER2 positive (14% vs 27%). The percentage of primary metastatic disease (M1) was 34% in both groups, while grade at diagnosis was more frequently G1/2 in the ILC group (73% vs 51%). The metastatic pattern was more often non-visceral only for the ILC group (26% vs 19%), and metastases were found more often in bone (52% vs 42%) and peritoneum (9% vs 2%) and less often in liver (20% vs 25%) and lung (7% vs 25%). Overall, pts with ILC were treated more often with endocrine therapy (ET) +/- CDK4/6-inhibitors (CDK4/6i) than pts with IDC (52% vs 33%), yet, ILC is more often HR-positive than IDC. Of pts receiving chemotherapy (CT) 53% of ILC and 56% of IDC tumors were treated with taxanes as first-line treatment. 20% of ILC vs. 24% of IDC tumors received a combination-CT. First-line treatment strategy was analyzed for the HR-positive, HER2-negative subgroup. From 2007-16 pts with ILC received more often ET (ILC (n=162) 54% vs IDC (n=696) 44%), while IDC were more often treated with CT first-line. Since approval of CDK4/6i, distribution of treatment strategies has been quite similar (ILC (n=123): CDK4/6i: 76%, ET: 15%, CT: 10% and IDC (n=311): CDK4/6i: 72%, ET: 12%, CT: 15%). Overall survival (OS) from start of first-line treatment was estimated for all pts recruited by 2016 (follow-up of at least 3 years). Median OS was comparable: ILC (n=224) 30.6 months (68% events, 95%-CI 26.1 - 36.9 months) and IDC (n=1217) 34.1 months (60% events, 95%-CI 30.6 - 38.4 months). For the HR-positive, HER2-negative subgroup, OS was also similar. A multivariate regression analysis on factors affecting OS will be presented. Conclusion Registries, like TMK/OPAL, can provide data on rare tumor subtypes. We show that ABC with an invasive lobular histology differs in receptor status (more often HR-positive) and metastatic pattern (e.g. more often non-visceral) from the invasive ductal subtype. Nevertheless, treatment strategies for first-line treatment are similar and median OS is comparable despite ILC pts being markedly older. Future research should focus on identifying pts who could benefit from personalized treatment approaches including tumor subtype as a factor to consider. Citation Format: Marc Thill, Mark-Oliver Zahn, Anja Welt, Elmar Stickeler, Arnd Nusch, Thomas Fietz, Jacqueline Rauh, Natalie Wetzel, Lisa Kruggel, Martina Jänicke, Norbert Marschner, Nadia Harbeck, Achim Wöckel, Thomas Decker, OPAL study group. Rare patients in routine care: Treatment and outcome in advanced invasive lobular breast cancer in the prospective German research platform OPAL [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS11-16.
    Type of Medium: Online Resource
    ISSN: 0008-5472 , 1538-7445
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    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2021
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  • 4
    In: International Journal of Cancer, Wiley, Vol. 152, No. 3 ( 2023-02), p. 458-469
    Abstract: There is no prospective, randomised head‐to‐head trial comparing first‐line FOLFIRINOX and gemcitabine/nab‐paclitaxel in advanced pancreatic cancer. We assess real‐world effectiveness and quality of life (QoL) of both regimens using a new prognostic score. This analysis includes 1540 patients with advanced pancreatic cancer from the prospective, clinical cohort study Tumour Registry Pancreatic Cancer separated into learning (n = 1027) and validation sample (n = 513). The Pancreatic Cancer Score (PCS) was developed using multivariate Cox regression. We compared overall survival (OS) and time to deterioration (TTD) for longitudinal QoL between first‐line FOLFIRINOX (n = 407) and gemcitabine/nab‐paclitaxel (n = 655) according to patients' prognostic risk, after inverse probability of treatment weighting (IPTW) by propensity score analysis. The PCS includes nine independent prognostic factors for survival: female sex, BMI ≥24/unknown, ECOG performance status ≥1, Charlson comorbidity index ≥1, tumour staging IV/unknown at primary diagnosis, liver metastases, bilirubin 〉 1.5× upper limit of normal (ULN), leukocytes 〉 ULN and neutrophil‐to‐lymphocyte ratio ≥4. Median OS of the validation sample was 11.4 (95% confidence interval [CI]: 10.4‐14.4), 8.5 (95% CI: 6.8‐9.6) and 5.9 months (95% CI: 4.0‐7.4) for favourable‐ (0‐3 risk factors), intermediate‐ (4‐5 factors) and poor‐risk group (6‐9 factors), respectively. After IPTW, only poor‐risk patients had significantly longer median OS and TTD of overall QoL with FOLFIRINOX (OS: 6.9 months, 95% CI: 3.9‐13.3; TTD: 10.6 months, 95% CI: 2.0‐14.1) vs gemcitabine/nab‐paclitaxel (OS: 4.0 months, 95% CI: 2.8‐4.8; TTD: 4.1 months, 95% CI: 2.4‐4.5). Our novel PCS may facilitate treatment decisions in clinical routine of advanced pancreatic cancer, since only poor‐risk, but not favourable‐risk patients, seem to benefit from intensified treatment with FOLFIRINOX.
    Type of Medium: Online Resource
    ISSN: 0020-7136 , 1097-0215
    URL: Issue
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    Language: English
    Publisher: Wiley
    Publication Date: 2023
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  • 5
    In: International Journal of Cancer, Wiley, Vol. 146, No. 5 ( 2020-03), p. 1307-1315
    Abstract: What's new? Over the past decade, the treatment landscape for locally advanced or metastatic renal cell carcinoma (mRCC) has dramatically changed. To date, however, guideline recommendations mainly address patients with clear cell mRCC, due to a lack of prospective Phase III evidence for the rarer, non‐clear cell mRCC subtypes. This is the first longitudinal, prospective cohort study evaluating treatment and survival of patients with papillary mRCC outside a prospective clinical trial setting. The presented real‐world data help bridge the evidence gap by revealing the frequent use and effectiveness of systemic clear cell mRCC therapy in papillary mRCC, with a seemingly inferior prognosis.
    Type of Medium: Online Resource
    ISSN: 0020-7136 , 1097-0215
    URL: Issue
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    Language: English
    Publisher: Wiley
    Publication Date: 2020
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  • 6
    In: Das Gesundheitswesen, Georg Thieme Verlag KG, Vol. 82, No. 03 ( 2020-03), p. e39-e66
    Abstract: Über Register können Fragestellungen zur Gesundheitsversorgung im Alltag untersucht werden. Sie sind daher eine wesentliche Methode der Versorgungsforschung. Das Deutsche Netzwerk Versorgungsforschung (DNVF) fördert die Qualität von Registern durch einen wissenschaftlichen Austausch, durch Fortbildungsangebote sowie durch Empfehlungen in Form eines Memorandums „Register für die Versorgungsforschung“. Die vorliegenden Empfehlungen stellen ein Update zur ersten Fassung des Memorandums von 2010 dar. Das Update beschreibt die Einsatzmöglichkeiten und Zielsetzungen von Registern in der Versorgungsforschung und stellt den aktuellen Stand zu allen Aspekten eines guten Designs und eines sachgerechten Betriebs von Registern dar. Das Memorandum kann Verantwortlichen für die Entwicklung eines Registers als Leitfaden zur Erreichung einer hohen Qualität dienen; potentiellen Nutzern von Daten und Ergebnissen aus Registern ermöglicht es, die Qualität eines Registers zu bewerten. Projektförderer und Gesundheitspolitik können sich bei der Rahmensetzung für Finanzierung und gesetzliche Anforderungen an den Qualitätskriterien orientieren. Neben einer Definition werden im Memorandum verschiedene für die Konzeption eines Registers relevante Bereiche vorgestellt. Dies umfasst die Phasen der Entwicklung eines Registers von der Planung über den Entwurf bis zur Umsetzung, die technische Organisation und den Betrieb eines Registers, die Auswertung von Registerdaten, die Berichterstattung über die Ergebnisse sowie den Datenschutz. Aus diesen Bereichen abgeleitete Kriterien zur Beurteilung der Qualität eines Registers werden beschrieben. Hierfür wird abschließend eine Checkliste präsentiert.
    Type of Medium: Online Resource
    ISSN: 0941-3790 , 1439-4421
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    Language: German
    Publisher: Georg Thieme Verlag KG
    Publication Date: 2020
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    SSG: 20,1
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  • 7
    In: Blood, American Society of Hematology, Vol. 124, No. 21 ( 2014-12-06), p. 4406-4406
    Abstract: Introduction Combination immunochemotherapy with cyclophosphamide, doxorubicine, vincristine, prednisone and the anti-CD20 monoclonal antibody rituximab (R-CHOP) is the standard of care for patients (pts) with previously untreated high-grade (aggressive) non-Hodgkin’s lymphoma (aNHL). Dose intensification of CHOP has shown ambiguous results (Pfreundschuh, 2004; Ohmachi, 2011), but the dose-dense two-weekly schedule (R-CHOP-14) was not found to be superior to the three-weekly schedule (R-CHOP-21) (Cunningham, 2013). Since clinical trials are restricted to highly selected pts, we investigated effectiveness of R-CHOP-14 and R-CHOP-21 in unselected pts with aNHL treated in routine practice by German office-based haematologists. Methods The open, longitudinal, multicentre, clinical registry on lymphoid neoplasms (TLN Registry, ClinicalTrial.gov registry NCT00889798) prospectively collects data on the treatment of pts with lymphoid B-cell neoplasms as administered by a network of over 260 German office-based haematologists. The choice of therapy is upon the discretion of the treating physician. All pts give their informed consent before onset of therapy. Pts are followed for 5 years. A broad set of data regarding patient and tumour characteristics, co-morbidities, all systemic treatments and response rates, date(s) of progression(s) and date of death are recorded. Automated plausibility and completeness checks with subsequently generated queries by the electronic data capture system ensure data reliability. In addition, data managers regularly check for plausibility and issue queries. Between May 2009 and August 2013 (date of present analysis), a total of 3,383 pts have been recruited. Results Of 477 pts with aNHL (95% DLBCL), recruited at the start of 1st-line therapy and treated with R-CHOP, 43% were treated with the two-weekly schedule (R-CHOP-14) and 57% received the three-weekly schedule (R-CHOP-21). Both schedules were applied for median 6 cycles (range 2-8); less than 6 cycles were applied in 23% and 30% of pts, respectively. Pts were median 67 years (yrs) old (33% ≤ 60 yrs), 47% female, 28% presented with tumour stage I (Ann Arbor), 27% with stage IV and 64% with at least one co-morbidity. 37% pts were of low risk (International Prognostic Index, IPI). Pts treated with the R-CHOP-14 or R-CHOP-21 differed in gender (female: 42% vs. 50%), performance status (ECOG 0: 44% vs. 40%) and pre-existing co-morbidities (60% vs. 67%), with no difference in age. Pts treated with R-CHOP-14 were diagnosed less often with tumour stage I (22% vs. 33%). Data on the application of Granulocyte colony-stimulating factor (G-CSF) were available for 381 pts. G-CSF was applied in 98% of pts treated with R-CHOP-14 and 61% of pts treated with R-CHOP-21. Pts treated with R-CHOP-21 and G-CSF were older (median 68 vs. 61yrs) than pts treated with R-CHOP-21 and no application of G-CSF. Objective response rate (ORR) as assessed by the local site was: 98% for R-CHOP-14 and 94% for R-CHOP-21; the clinical (unconfirmed) complete remission rate (CRu) was 65% for R- CHOP-14 and 70% for R-CHOP-21 (p=0.32). After a median follow-up of 22 months (maximum 51 months), 2-year progression-free survival rate (PFS) is 74% (1-year: 84%) for R-CHOP-14 and 82% (1-year: 85%) for R-CHOP-21. 2-year overall survival rate (OS) is 86% (1-year: 91%) for R-CHOP-14 and 85% (1-year: 89%) for R-CHOP-21. At time of analysis, 9% of pts (R-CHOP-14) and 8% (R-CHOP-21) have received a 2nd-line therapy. Overall, 7% of pts have been lost to follow-up. At this point, the high rate of pts alive without progression ( 〉 80%) precluded multivariate regression analyses regarding factors affecting PFS or OS. Conclusion Our data show that in routine practice, independent of age, pts with good performance status and low burden of co-morbities are more likely to receive the dose-dense two-weekly R-CHOP-14 schedule than the three-weekly R-CHOP-21 schedule as 1st-line treatment. First outcome data show that the effectiveness (ORR, PFS and OS) of both schedules is similar despite the differences in pts selection. DLBCL: Diffuse Large B-cell Lymphoma References: Cunningham et al., The Lancet. Mai 2013;381(9880):1817–26 │ Ohmachi K et al., Ann Oncol. 2011;22(6):1382–91 │ Pfreundschuh M et al., Blood. 2004;104(3):634–41 Disclosures No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2014
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  • 8
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 75, No. 9_Supplement ( 2015-05-01), p. P4-05-13-P4-05-13
    Abstract: Deletions of chromosome 10q23, including the PTEN (phosphatase and tensin homolog) locus, are known to occur in breast cancer, but systematic analyses of its clinical relevance are lacking. We thus analyzed a tissue microarray (TMA) with 2,197 breast cancers by fluorescence in-situ hybridization (FISH) using a PTEN-specific probe, and found deletions in 19% of no special type, 9% of lobular, 46% of medullary and 4% of tubular cancers. 98.7% of deletions were heterozygous and 1.3% were homozygous. PTEN deletion was significantly linked to advanced tumor stage (p=0.0054), high tumor grade (p & lt;0.0001), high tumor cell proliferation (Ki67 Labeling Index; p & lt;0.0001), and shortened overall survival (p=0.0090). PTEN deletions were inversely associated with features of luminal type breast cancers (ER/PR positivity, CCND1 amplification). PTEN deletions were strongly linked to amplification of genes involved in the PTEN/AKT pathway such as MYC (p=0.0430) and HER2 (p=0.0065). Remarkably the combined analysis of MYC, HER2, and PTEN aberrations suggested that aberrations of multiple PTEN/AKT pathway genes have a strong additive effect on breast cancer prognosis. Cancers with two or three of these aberrations behaved significantly worse than cancers with none or one of these changes (p & lt;0,0001). The particularly poor prognosis of patients with HER2 amplification and PTEN deletions challenges the concept of PTEN deletions interfering with trastuzumab therapy. In conclusion, PTEN deletion occurs in a relevant fraction of breast cancers, and is linked to aggressive tumors. Reduced PTEN function cooperates with MYC and HER2 activation in conferring aggressive phenotype to cancer cells. Citation Format: Eike Burandt, Martina Kluth, Valerie Kopperschmidt, Anja Mittenzwei, Annette Lebeau, Volkmar Müller, Isabell Witzel, Fritz Jänicke, Stefan Geist, Peter Paluchowski, Christian Wilke, Uwe Heilenkötter, Rainer Krech, Albert von d Assen, Ronald Simon, Patrick Lebok. PTEN deletion is linked to adverse phenotype and poor prognosis in breast cancer [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P4-05-13.
    Type of Medium: Online Resource
    ISSN: 0008-5472 , 1538-7445
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    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2015
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  • 9
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 80, No. 4_Supplement ( 2020-02-15), p. P2-17-01-P2-17-01
    Abstract: Introduction Tumor Registries give insight into routine treatment and complement the knowledge derived from randomized controlled trials (RCT), since characteristics of patients from RCTs often differ from those of patients in routine care. Furthermore, follow-up of patients in registries is generally longer which gives the possibility to analyze sequential treatments. Since 2007 the Tumor Registry Breast Cancer (TMK, NCT01351584) has prospectively collected data on treatment and outcome of patients with breast cancer in Germany. Among other topics, insights into “real-world” treatment and outcome and long-term observation of quality of life have been published. Since 2017 the registry platform OPAL (NCT03417115) has extended the work of the TMK by recruiting patients with advanced breast cancer (ABC) from all specialties (medical and gynecologic oncologists). The main aims are to observe the impact of novel treatments on patient outcome, and to identify areas for improvement of quality of care. Methods OPAL started in December 2017. Patients are prospectively recruited at start of their first systemic treatment for ABC. Follow-up continues until death or up to 5 years. There is no treatment specification. Detailed information on all (sequential) treatments, patient and tumor characteristics, physician-reported factors regarding treatment decision making, biomarker testing, outcomes (e.g. best response, progression-free and overall survival) are collected in a web-based data capture system with implemented checks for completeness and plausibility. Data are monitored by data management and on-site. Patient-reported outcomes (PROs) are collected at start of treatment and every 3 months thereafter. Patients can also give informed consent for their tumor samples to be used in future translational research (virtual biobank). All patient data remain in Germany. Here, first combined data from the TMK and OPAL (database as of 01.04.2019) are presented. Results Since 2007, 5076 patients have been recruited. Patients with ABC (n=2105, 434 since the start of OPAL) have a median age of over 60 years at start of treatment; about 60% have comorbidities. For patients with hormone-receptor positive (HRpos)/HER2 negative (HER2neg) ABC, first-line treatment has changed over the years. From 2007-11 (n=458) 60% of patients started with chemotherapy, decreasing to 48% in 2012-16 (n=528) and to 23% in 2018-19 (n=170) with 58% of patients now being treated with CDK4/6-inhibitor. First-line of HER2pos ABC has also changed from 79% of patients receiving trastuzumab (TRA) between 2007-12 (n=268) to 78% of patients receiving dual-blockade with TRA/pertuzumab in 2018-19 (n=97) and 10% receiving TRA only. About 25% of patients treated with TRA in 2018-19 received a biosimilar. Median overall survival (OS) of patients with start of first-line therapy between 2007-16 is currently 15 months for triple-neg (74% events), 34 months for HRpos/HER2neg (59% events), 40 months for HER2pos (52% events); median OS has not yet been reached for patients in OPAL. Conclusions For patients with HRpos/HER2neg ABC, a shift towards more endocrine therapy in the first-line setting, and a quick implementation of CDK4/6-inhibitors after their approval can be observed. In patients with HER2pos ABC, integration of trastuzumab biosimilars into routine care has started. Prognosis for patients with triple-negative ABC remains poor and new treatment options are urgently needed. OPAL together with TMK will allow to follow changes in treatment of patients with ABC in a “real world” setting in Germany, the application of sequential treatments, and their impact on clinical as well as patient-reported outcome. Citation Format: Elmar Stickeler, Nadia Harbeck, Marc Thill, Arnd Nusch, Marco Chiabudini, Lisa Kruggel, Martina Jänicke, Norbert Marschner, Mark-Oliver Zahn, Anja Welt, Achim Wöckel, Thomas Decker, OPAL Study Group. Therapy of advanced breast cancer for patients with hormone receptor-positive/HER2-negative and HER2-positive tumors is changing in real life: First results from the prospective, national research platform OPAL for patients with advanced breast cancer in Germany [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-17-01.
    Type of Medium: Online Resource
    ISSN: 0008-5472 , 1538-7445
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    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2020
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  • 10
    In: International Journal of Cancer, Wiley, Vol. 144, No. 5 ( 2019-03), p. 981-990
    Abstract: What's new? More than four‐fifths of patients with pancreatic cancer present with locally advanced, inoperable (LAPC) or metastatic (MPC) disease at diagnosis. Beyond clinical trials, relatively little data is available on survival outcomes for these patients. Here, real‐world data, derived from an unselected cohort of 1,174 patients enrolled between 2014 and 2017 in a prospective study in Germany, show that the vast majority of first‐line therapies given to LAPC/MPC patients consisted of either gemcitabine monotherapy, nab ‐paclitaxel plus gemcitabine, or FOLFIRINOX. About 40 percent of the patients received second‐line therapy. Overall cohort survival was comparable to that reported for randomized clinical trials.
    Type of Medium: Online Resource
    ISSN: 0020-7136 , 1097-0215
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    Language: English
    Publisher: Wiley
    Publication Date: 2019
    detail.hit.zdb_id: 218257-9
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