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Factors affecting the efficacy of gemcitabine and nab-paclitaxel (paclitaxel + albumin) combination in the Russian patient population: results of a multicenter retrospective study

https://doi.org/10.21518/2079-701X-2019-19-74-82

Abstract

Introduction. The randomized MPACT study showed that nab-paclitaxel plus gemcitabine results in statistically significantly longer life expectancy. The objective of this retrospective study is to obtain relevant data on the efficacy of this combination in real clinical practice in Russia. Materials and methods. The study included patients with morphologically proven locally advanced or metastatic pancreatic cancer, with a general condition assessed on the ECOG scale between 0-2, which received gemcitabine and nab-paclitaxel. Immediate and long-term treatment outcomes were evaluated. Results. 142 patients, who received treatment from 2009 to 2019 in 17 centers from 11 regions of Russia, were included in the study. Assessment of the objective effect was made in 134 patients. Objective effects were detected in 34 (25.4%) cases. The median time-to-progression was 6.1 months (95% confidence interval (CI) 4.8-7.4),  the median length of life was 14.2 months (95% CI 10.6-17.9). An elevated CA19-9 level is the only independent adverse prognostic factor for progression-free survival (RR = 8.0, 95% CI 1.4 -43.8, p = 0.02) according to Cox multivariate regression analysis. The number of previously conducted chemotherapy lines (p = 0.34), ECOG status (p = 0.70), age over 70 years (p = 0.45), serious comorbidity (p = 0.97) did not have a statistically significant effect on progression-free survival. Findings. The gemcitabine and nab-paclitaxel combination has a relatively higher efficacy in advanced pancreatic cancer. The immediate and long-term results of its use in real clinical practice in Russia are consistent with data obtained in the Western countries.

About the Authors

I. A. Pokataev
Federal State Budget Institution «N.N. Blokhin National Medical Research Center of Oncology» of the Ministry of Health of the Russian Federation
Russian Federation

Cand. of Sci. (Med.), Lead Researcher, Department of Clinical Pharmacology and Chemotherapy

23 Kashirskoe shosse, Moscow, 115478, Russia



M. A. Lyadova
Limited Liability Company «Moscow Reabilitation Center»
Russian Federation

Cand. of Sci. (Med.), Head of Oncology Department

22 Akademika Pavlova St., Moscow, 121359, Russia



M. Yu. Fedyanin
Federal State Budget Institution «N.N. Blokhin National Medical Research Center of Oncology» of the Ministry of Health of the Russian Federation
Russian Federation

Dr. of Sci. (Med.), Senior Researcher, Department of Clinical Pharmacology and Chemotherapy

23 Kashirskoe shosse, Moscow, 115478, Russia



A. A. Tryakin
Federal State Budget Institution «N.N. Blokhin National Medical Research Center of Oncology» of the Ministry of Health of the Russian Federation
Russian Federation

Dr. of Sci. (Med.), Principal Researcher, Department of Clinical Pharmacology and Chemotherapy

23 Kashirskoe shosse, Moscow, 115478, Russia



V. F. Chubenko
State Budget Healthcare Institution «St. Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncology)»
Russian Federation

Cand. of Sci. (Med.), Head of Chemotherapy Department

Lit. A, 68А Leningradskaya St., Pesochnyy Settlement, Saint Petersburg, 197758, Russia



F. V. Moiseenko
State Budget Healthcare Institution «St. Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncology)»
Russian Federation

Dr. of Sci. (Med.), Head of Oncological Chemotherapeutic (Antitumor Drug Therapy) Department of Biotherapy

Lit. A, 68А Leningradskaya St., Pesochnyy Settlement, Saint Petersburg, 197758, Russia



L. A. Zagorskaya
State Budget Healthcare Institution «St. Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncology)»
Russian Federation

Oncologist, Chemotherapy Department

Lit. A, 68А Leningradskaya St., Pesochnyy Settlement, Saint Petersburg, 197758, Russia



M. L. Stepanova
State Budget Healthcare Institution «St. Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncology)»
Russian Federation

Oncologist

Lit. A, 68А Leningradskaya St., Pesochnyy Settlement, Saint Petersburg, 197758, Russia А



A. V. Androsova
Chemotherapy Department No. 11, Saint Petersburg State Healthcare Institution «City Clinical Oncology Center»
Russian Federation

Oncologist

56 Prospekt Veteranov, Saint Petersburg, 198255, Russia



D. A. Nosov
Federal State Budget Institution Central Clinical Hospital of the Presidential Administration of the Russian Federation
Russian Federation

Dr. of Sci. (Med.), Prof. of RAS, Head of Oncological Department of Anticancer Drug Therapy (with Day Hospital)

15 Marshala Timoshenko St., Moscow, 121359, Russia 


N. V. Karpova
Federal State Budget Institution «Central Clinical Hospital of the Presidential Administration of the Russian Federation»
Russian Federation

15 Marshala Timoshenko St., Moscow, 121359, Russia 


O. I. Kit
Federal State Budget Institution «Rostov Research Institute of Oncology» of the Ministry of Health of the Russian Federation
Russian Federation

corr. Member of RAS, Dr. of Sci. (Med.), Professor, General Director

63 14-ya Liniya, Rostov-on-Don, 344037, Russia 


L. Yu. Vladimirova
Federal State Budget Institution «Rostov Research Institute of Oncology» of the Ministry of Health of the Russian Federation
Russian Federation

Dr. of Sci. (Med.), Professor, Head of Medication-Based Tumor Treatment

63 14-ya Liniya, Rostov-on-Don, 344037, Russia


I. L. Popova
Federal State Budget Institution «Rostov Research Cancer Institute» of the Ministry of Health of the Russian Federation
Russian Federation

Cand. of Sci. (Med.), Chemotherapeutist, Department of Cancer Drug Therapy No. 1

63 14-ya Liniya, Rostov-on-Don, 344037, Russia



A. V. Belonogov
Center for Targeted Therapy LLC
Russian Federation

Cand. of Sci. (Med.)

59, Bldg. 5, Talsinskaya St., Shchelkovo, 141109, Russia



D. M. Ponomarenko
State Budget Healthcare Institution «Regional Cancer Center»
Russian Federation

Cand. of Sci. (Med.), Oncologist of the Highest Qualification Grade, Head of Department of Cancer Drug Therapy No. 1

32 Frunze St., Irkutsk, 664035, Russia



D. Yu. Yukalchuk
State Budget Healthcare Institution «Regional Cancer Center»
Russian Federation

Oncologist of the Highest Qualification Grade, Department of Cancer Drug Therapy No. 1

32 Frunze St., Irkutsk, 664035, Russia



V. E. Shikina
Federal State Budget Institution «Federal Research Clinical Centre for Specialized Healthcare and Medical Technology of the Federal Medical Biological Agency»
Russian Federation

Cand. of Sci. (Med.), Oncologist, Head of Department of Cancer Drug Therapy

28 Orekhovyy Bul., Moscow, 115682, Russia



N. V. Ivanova
Services, State Autonomous Healthcare Institution of Tyumen Region «Medical City» Multidisciplinary Clinical Medical Center»
Russian Federation

Head of Medical and Surgical

32 Barnaul’skaya St., Tyumen, 625041, Russia



A. I. Khasanova
State Autonomous Healthcare Institution «Tatarstan Regional Clinical Cancer Center of the Ministry of Health of the Republic of Tatarstan», Federal State Budget Institution «N.N. Blokhin National Medical Research Center of Oncology» of the Ministry of Health of the Russian Federation, Privolzhsky Branch
Russian Federation

Cand. of Sci. (Med.), Head of Day Hospital No. 1

Senior Researcher

29 Sibirskiy Trakt St., Kazan, Republic of Tatarstan, 420029, Russia



A. D. Kruglov
State Budget Healthcare Institution of Moscow «The Loginov Moscow Clinical Scientific Center» of Moscow Health Department
Russian Federation

Oncologist

I86, Shosse Entuziastov, Moscow, 111123, Russia



I. Yu. Stradaeva
Chemotherapy Department, 13 Moscow Regional Oncology Center
Russian Federation

Head

6 Kuibysheva St., Balashikha Urban District, 143900, Russia



A. S. Perepletova
State Budget Institution of Astrakhan Region «Regional Cancer Center»
Russian Federation

Oncologist

57 Borisa Alekseeva St., Astrakhan, 414041, Russia



V. M. Filippova
State Budget Institution of Astrakhan Region «Regional Cancer Center»
Russian Federation

Oncologist

57 Borisa Alekseeva St., Astrakhan, 414041, Russia



N. L. Buzova
Autonomous Institution «Chuvash Regional Clinical Cancer Center» of the Ministry of Health of the Russian Federation
Russian Federation

Oncologist

31 Gladkova St., Cheboksary, 428020, Chuvash Republic



O. V. Khavaneva
Autonomous Institution «Chuvash Regional Clinical Cancer Center» of the Ministry of Health of the Russian Federation
Russian Federation

Oncologist

31 Gladkova St., Cheboksary, 428020, Chuvash Republic



Kh. S. Musaeva
State Budget Institution «Chechen Regional Clinical Cancer Center» of the Ministry of Health of the Russian Federation
Russian Federation

Oncologist

81 Leonova Str., Groznyy, 364029, Chechen Republic



A. Yu. Goryainova
State Budget Healthcare Institution «Clinical Oncology Dispensary No.1
Russian Federation

Oncologist

OO146 Dimitrova St., Krasnodar, 350040, Russia



O. V. Romanchuk
State Budget Healthcare Institution of Moscow «Oncology Dispensary No. 4 of Moscow Healthcare Department»
Russian Federation
7 Medikov St., Moscow, 115304, Russia



I. Sh. Tespizhek
State Budget Heathcare Institution «Buryat Clinical Republican Oncology Center»
Russian Federation

Oncologist

32 Pirogova St., Ulan-Ude, 670047, Republic of Buryatia


S. A. Tyulyandin
Federal State Budget Institution «N.N. Blokhin National Medical Research Center of Oncology» of the Ministry of Health of the Russian Federation
Russian Federation

Dr. of Sci. (Med.), Professor, Head of Department of Clinical Pharmacology and Chemotherapy

23 Kashirskoe shosse, Moscow, 115478, Russia



References

1. Burris H.A., Moore M.J., Andersen J., Green M.R., Rothenberg M.L., Modiano M.R., Cripps M.C., Portenoy R.K., Storniolo A.M., Tarassoff P. et al. Improvements in Survival and Clinical Benefit with Gemcitabine as First-Line Therapy for Patients with Advanced Pancreas Cancer: A Randomized Trial. JCO. 1997;15(6):2403–2413. doi: 10.1200/JCO.1997.15.6.2403.

2. Berlin J.D., Catalano P., Thomas J.P., Kugler J.W., Haller D.G., Benson A.B. Phase III Study of Gemcitabine in Combination With Fluorouracil Versus Gemcitabine Alone in Patients With Advanced Pancreatic Carcinoma: Eastern Cooperative Oncology Group Trial E2297. JCO. 2002;20(15):3270–3275. doi: 10.1200/JCO.2002.11.149.

3. Rocha Lima C.M., Green M.R., Rotche R., Miller W.H., Jeffrey G.M., Cisar L.A., Morganti A., Orlando N., Gruia G., Miller L.L. Irinotecan Plus Gemcitabine Results in No Survival Advantage Compared With Gemcitabine Monotherapy in Patients With Locally Advanced or Metastatic Pancreatic Cancer Despite Increased Tumor Response Rate. JCO. 2004;22(18):3776–3783. doi: 10.1200/JCO.2004.12.082.

4. Oettle H., Richards D., Ramanathan R.K., van Laethem J.L., Peeters M., Fuchs M., Zimmermann A., John W., Von Hoff D., Arning M. et al. A Phase III Trial of Pemetrexed plus Gemcitabine versus Gemcitabine in Patients with Unresectable or Metastatic Pancreatic Cancer. Annals of Oncology. 2005;16(10):1639–1645. doi: 10.1093/annonc/mdi309.

5. Louvet C., Labianca R., Hammel P., Lledo G., Zampino M.G., André T., Zaniboni A., Ducreux M., Aitini E., Taïeb J. et al. Gemcitabine in Combination With Oxaliplatin Compared With Gemcitabine Alone in Locally Advanced or Metastatic Pancreatic Cancer: Results of a GERCOR and GISCAD Phase III Trial. JCO. 2005;23(15):3509–3516. doi: 10.1200/JCO.2005.06.023.

6. Heinemann V., Quietzsch D., Gieseler F., Gonnermann M., Schönekäs H., Rost A., Neuhaus H., Haag C., Clemens M., Heinrich B. et al. Randomized Phase III Trial of Gemcitabine Plus Cisplatin Compared With Gemcitabine Alone in Advanced Pancreatic Cancer. JCO. 2006;24(24):3946–3952. doi: 10.1200/JCO.2005.05.1490.

7. Herrmann R., Bodoky G., Ruhstaller T., Glimelius B., Bajetta E., Schüller J., Saletti P., Bauer J., Figer A., Pestalozzi B. et al. Gemcitabine Plus Capecitabine Compared With Gemcitabine Alone in Advanced Pancreatic Cancer: A Randomized, Multicenter, Phase III Trial of the Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group. JCO. 2007;25(16):2212–2217. doi: 10.1200/JCO.2006.09.0886.

8. Poplin E., Feng Y., Berlin J., Rothenberg M.L., Hochster H., Mitchell E., Alberts S., O’Dwyer P., Haller D., Catalano P. et al. Phase III, Randomized Study of Gemcitabine and Oxaliplatin Versus Gemcitabine (Fixed-Dose Rate Infusion) Compared With Gemcitabine (30-Minute Infusion) in Patients With Pancreatic Carcinoma E6201: A Trial of the Eastern Cooperative Oncology Group. JCO. 2009;27(23):3778–3785. doi: 10.1200/JCO.2008.20.9007.

9. Cunningham D., Chau I., Stocken D.D., Valle J.W., Smith D., Steward W., Harper P.G., Dunn J., TudurSmith C., West J. et al. Phase III Randomized Comparison of Gemcitabine Versus Gemcitabine Plus Capecitabine in Patients With Advanced Pancreatic Cancer. JCO. 2009;27(33):5513–5518. doi: 10.1200/JCO.2009.24.2446.

10. Colucci G., Labianca R., Di Costanzo F., Gebbia V., Cartenì G., Massidda B., Dapretto E., Manzione L., Piazza E., Sannicolò M. et al. Randomized Phase III Trial of Gemcitabine Plus Cisplatin Compared With Single-Agent Gemcitabine As First-Line Treatment of Patients With Advanced Pancreatic Cancer: The GIP-1 Study. JCO. 2010;28(10):1645–1651. doi: 10.1200/JCO.2009.25.4433.

11. Von Hoff D.D., Ervin T., Arena F.P., Chiorean E.G., Infante J., Moore M., Seay T., Tjulandin S.A., Ma W.W., Saleh M.N. et al. Increased Survival in Pancreatic Cancer with Nab-Paclitaxel plus Gemcitabine. N Engl J Med. 2013;369(18):1691–1703. doi: 10.1056/NEJMoa1304369.

12. Tabernero J., Chiorean E.G., Infante J.R., Hingorani S.R., Ganju, V., Weekes C., Scheithauer W., Ramanathan R.K., Goldstein D., Penenberg D.N. et al. Prognostic Factors of Survival in a Randomized Phase III Trial (MPACT) of Weekly NabPaclitaxel Plus Gemcitabine Versus Gemcitabine Alone in Patients With Metastatic Pancreatic Cancer. The Oncologist. 2015;20(2):143–150. doi: 10.1634/theoncologist.2014-0394.

13. Giordano G., Milella M., Lo Re G., Di Marco M., Melisi D., Passardi A., Febbraro A., Iop A., Vaccaro V., Foltran L. et al. Nab-Paclitaxel (Nab-P) and Gemcitabine (G) First-Line Chemotherapy (CT) in Patients (Pts) with Metastatic Pancreatic Cancer (MPC) Who Relapsed after Adjuvant Treatment (ADJ T): A «REAL LIFE» Study. JCO. 2017;35(4):396–396. doi: 10.1200/JCO.2017.35.4_suppl.396.

14. Scheithauer W., Ramanathan R.K., Moore M., Macarulla T., Goldstein D., Hammel P., Kunzmann V., Liu H., McGovern D., Romano A. et al. Dose Modification and Efficacy of Nab -Paclitaxel plus Gemcitabine vs . Gemcitabine for Patients with Metastatic Pancreatic Cancer: Phase III MPACT Trial. Journal of Gastrointestinal Oncology. 2016;7(3)


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For citations:

Pokataev IA, Lyadova MA, Fedyanin MY, Tryakin AA, Chubenko VF, Moiseenko FV, Zagorskaya LA, Stepanova ML, Androsova AV, Nosov DA, Karpova NV, Kit OI, Vladimirova LY, Popova IL, Belonogov AV, Ponomarenko DM, Yukalchuk DY, Shikina VE, Ivanova NV, Khasanova AI, Kruglov AD, Stradaeva IY, Perepletova AS, Filippova VM, Buzova NL, Khavaneva OV, Musaeva KS, Goryainova AY, Romanchuk OV, Tespizhek IS, Tyulyandin SA. Factors affecting the efficacy of gemcitabine and nab-paclitaxel (paclitaxel + albumin) combination in the Russian patient population: results of a multicenter retrospective study. Meditsinskiy sovet = Medical Council. 2019;(19):74-82. (In Russ.) https://doi.org/10.21518/2079-701X-2019-19-74-82

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