Toxicity and efficacy of gemcitabine plus nab-paclitaxel (paclitaxel + albumin) in a Russian patient population: results of a multicenter retrospective study

I. A. Pokataev; M. A. Lyadova; М. Yu. Fedyanin; A. A. Tryakin; V. A. Chubenko; F. V. Moiseenko; L. A. Zagorskaya; М. L. Stepanova; A. V. Androsova; D. A. Nosov; N. V. Karpova; О. I. Kit; L. Yu. Vladimirova; I. L. Popova; A. V. Belonogov; D. М. Ponomarenko; D. Yu. Yukalchuk; V. Е. Shikina; N. V. Ivanova; А. I. Khasanova; А. D. Kruglov; I. Yu. Stradaeva; А. S. Perepletova; V. М. Filippova; N. L. Buzova; О. V. Khavaeva; Kh. S. Musaeva; А. Yu. Goryainova; О. V. Romanchuk; I. Sh. Tespizhek; S. А. Tyulyandin

doi:10.18027/2224-5057-2019-9-3-20-30

Toxicity and efficacy of gemcitabine plus nab-paclitaxel (paclitaxel + albumin) in a Russian patient population: results of a multicenter retrospective study

I. A. Pokataev, M. A. Lyadova, М. Yu. Fedyanin, A. A. Tryakin, V. A. Chubenko, F. V. Moiseenko, L. A. Zagorskaya, М. L. Stepanova, A. V. Androsova, D. A. Nosov, N. V. Karpova, О. I. Kit, L. Yu. Vladimirova, I. L. Popova, A. V. Belonogov, D. М. Ponomarenko, D. Yu. Yukalchuk, V. Е. Shikina, N. V. Ivanova, А. I. Khasanova, А. D. Kruglov, I. Yu. Stradaeva, А. S. Perepletova, V. М. Filippova, N. L. Buzova, О. V. Khavaeva, Kh. S. Musaeva, А. Yu. Goryainova, О. V. Romanchuk, I. Sh. Tespizhek, S. А. Tyulyandin

https://doi.org/10.18027/2224-5057-2019-9-3-20-30

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Abstract

Introduction. The results of randomized MPACT study have demonstrated that the addition of nab-paclitaxel to gemcitabine leads to a statistically significant increase in life expectancy. The main objective of this retrospective study was to obtain up-to-date efficacy and toxicity data for this drug combination in Russian real-world clinical setting.

Materials and methods. The study enrolled patients with morphologically confirmed locally advanced or metastatic pancreatic cancer who had ECOG Performance Status scores of 0-2 and received treatment with gemcitabine and nab-paclitaxel. Immediate and long-term outcomes, as well as treatment toxicity and dose modifications, were assessed.

Results. The study included 142 patients who received treatment from 2009 to 2019 at 17 centers in 11 regions of Russia. Full dose gemcitabine and nab-paclitaxel were administered at baseline in 74 % of the cases. The median number of chemotherapy cycles was 4 (range, from 1 to 16). Nab-paclitaxel dose was reduced in 32 % of the cases, and that of gemcitabine in 23 % of them. Regression analysis revealed no prognostic factors associated with increased toxicity of gemcitabine and nab-paclitaxel administration. However, previous use of two or more chemotherapy lines had an impact on decisions made by physicians, making them reduce the baseline dose of gemcitabine and/or nab-paclitaxel (OR=6.1, 95% CI 1.5-24.2, р=0.010). An objective response was assessed in 134 subjects with positive response observed in 34 cases (25.4 %). The median time to progression was found to be 6.1 months, and the median life expectancy was 14.2 months.

Conclusions. The combination of gemcitabine and nab-paclitaxel exhibits comparatively high efficacy. The acceptable toxicity profile allows its use in selected patients even with ECOG 2 and in the presence of serious comorbidities.

Keywords

pancreatic cancer, gemcitabine, nab-paclitaxel, chemotherapy

About the Authors

I. A. Pokataev

N.N. Blokhin National Medical Research Center of Oncology
Russian Federation

Ilya A. Pokatayev - MD, PhD, senior research fellow, Department of Clinical Pharmacology and Chemotherapy.

Moscow

Competing Interests: not

M. A. Lyadova

Moscow Centre of Rehabilitation
Russian Federation

Marina. А. Lyadova - MD, PhD, Head of Oncology Department

Competing Interests: not

М. Yu. Fedyanin

N.N. Blokhin National Medical Research Center of Oncology
Russian Federation

Mikhail Yu. Fedyanin - MD, PhD, DSc, senior research fellow, Department of Clinical Pharmacology and Chemotherapy.

Moscow

Competing Interests: not

A. A. Tryakin

N.N. Blokhin National Medical Research Center of Oncology
Russian Federation

Alexey A. Tryakin - MD, PhD, DSc, Chief Researcher, Department of Clinical Pharmacology and Chemotherapy.

Moscow

Competing Interests: not

V. A. Chubenko

Saint Petersburg Clinical Research and Practice Centre for Specialized Care (Oncological)
Russian Federation

Vyacheslav A. Chubenko - MD, PhD, Head of the Department of Chemotherapy

Competing Interests: not

F. V. Moiseenko

Saint Petersburg Clinical Research and Practice Centre for Specialized Care (Oncological)
Russian Federation

Fyodor V. Moiseenko - MD, PhD, DSc, Head of the Anti-cancer Chemotherapy (antitumor pharmacological therapy) Department of Biotherapy

Competing Interests: not

L. A. Zagorskaya

Saint Petersburg Clinical Research and Practice Centre for Specialized Care (Oncological)
Russian Federation

Lyudmila A. Zagorskaya - oncologist, Department of Chemotherapy

Competing Interests: not

М. L. Stepanova

Saint Petersburg Clinical Research and Practice Centre for Specialized Care (Oncological)
Russian Federation

Maria L. Stepanova – oncologist

Competing Interests: not

A. V. Androsova

Municipal Clinical Oncology Dispensary
Russian Federation

Aleksandra V. Androsova - oncologist of Department of Chemotherapy № 11.

Saint Petersburg

Competing Interests: not

D. A. Nosov

Central Clinical Hospital of the Management Affair of President Russian Federation
Russian Federation

Dmitriy A. Nosov - MD, PhD, DSc, Professor of the RAS, Head of the Oncology Department of Antitumor Pharmacological Therapy (with Day Hospital).

Moscow

Competing Interests: not

N. V. Karpova

Central Clinical Hospital of the Management Affair of President Russian Federation
Russian Federation

Natalya V. Karpova

Moscow

Competing Interests: not

О. I. Kit

Rostov Research Institute of Oncology of the Ministry of Health of the Russian Federation
Russian Federation

Oleg I. Kit - MD, PhD, DSc, Prof., Corresponding Member of the Russian Academy of Sciences.

Rostov-on-Don
Competing Interests: not

L. Yu. Vladimirova

Rostov Research Institute of Oncology of the Ministry of Health of the Russian Federation
Russian Federation

Lyubov Yu. Vladimirova - MD, PhD, DSc, Prof., Head of the Division of Anti-cancer Chemotherapy.

Rostov-on-Don

Competing Interests: not

I. L. Popova

Rostov Research Institute of Oncology of the Ministry of Health of the Russian Federation
Russian Federation

Irina L. Popova - MD, PhD, oncologist, Anti-cancer Chemotherapy Department No. 1.

Rostov-on-Don
Competing Interests: not

A. V. Belonogov

MEDSI Clinic
Russian Federation

Aleksandr V. Belonogov

Moscow

Competing Interests: not

D. М. Ponomarenko

Regional Oncology Dispensary
Russian Federation

Dmitriy М. Ponomarenko - MD, PhD, oncologist of higher education qualifications, Head of Department № 1 of Antitumor Pharmacological Therapy.

Irkutsk

Competing Interests: not

D. Yu. Yukalchuk

Regional Oncology Dispensary
Russian Federation

Denis Yu. Yukalchuk = oncologist of higher education qualifications, Department № 1 of Antitumor Pharmacological Therapy.

Irkutsk

Competing Interests: not

V. Е. Shikina

Federal Research and Clinical Centre of Specialized Care and Medical Technology of the Federal Medico-Biological Agency of the Russian Federation
Russian Federation

Valentina Е. Shikina - MD, PhD, oncologist, Head of the Oncology Department of Antitumor Pharmacological Therapy.

Moscow

Competing Interests: not

N. V. Ivanova

Multispecialty Clinical Medical Centre «Medical City»
Russian Federation

Natalya V. Ivanova - Head of the Medical and Surgical Service.

Tyumen

Competing Interests: not

А. I. Khasanova

Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan
Russian Federation

Alfiya I. Khasanova - MD, PhD, oncologist, Head of Day Hospital No. 1.

Kazan

Competing Interests: not

А. D. Kruglov

Moscow Clinical Research Centre named after A.S. Loginov
Russian Federation

Competing Interests: not

I. Yu. Stradaeva

Moscow Regional Oncology Dispensary
Russian Federation

Competing Interests: not

А. S. Perepletova

Regional Oncology Dispensary
Russian Federation

Competing Interests: not

V. М. Filippova

Regional Oncology Dispensary
Russian Federation

Competing Interests: not

N. L. Buzova

Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Chuvashia
Russian Federation

Competing Interests: not

О. V. Khavaeva

Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Chuvashia
Russian Federation

Competing Interests: not

Kh. S. Musaeva

Republican Oncology Dispensary
Russian Federation

Competing Interests: not

А. Yu. Goryainova

Clinical Oncology Dispensary No. 1
Russian Federation

Competing Interests: not

О. V. Romanchuk

Oncology Dispensary No. 4 of the Department of Health of the City of Moscow
Russian Federation

Competing Interests: not

I. Sh. Tespizhek

Buryat Republican Clinical Oncology Dispensary
Russian Federation

Competing Interests: not

S. А. Tyulyandin

N.N. Blokhin National Medical Research Center of Oncology
Russian Federation

Competing Interests: not

References

1. Von Hoff D.D. et al. Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine // N. Engl. J. Med. 2013. Vol. 369, № 18. P. 1691-1703.

2. Tabernero J. et al. Prognostic Factors of Survival in a Randomized Phase III Trial (MPACT) of Weekly nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone in Patients With Metastatic Pancreatic Cancer // The Oncologist. 2015. Vol. 20, № 2. P. 143-150.

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For citations:

Pokataev I.A., Lyadova M.A., Fedyanin М.Yu., Tryakin A.A., Chubenko V.A., Moiseenko F.V., Zagorskaya L.A., Stepanova М.L., Androsova A.V., Nosov D.A., Karpova N.V., Kit О.I., Vladimirova L.Yu., Popova I.L., Belonogov A.V., Ponomarenko D.М., Yukalchuk D.Yu., Shikina V.Е., Ivanova N.V., Khasanova А.I., Kruglov А.D., Stradaeva I.Yu., Perepletova А.S., Filippova V.М., Buzova N.L., Khavaeva О.V., Musaeva Kh.S., Goryainova А.Yu., Romanchuk О.V., Tespizhek I.Sh., Tyulyandin S.А. Toxicity and efficacy of gemcitabine plus nab-paclitaxel (paclitaxel + albumin) in a Russian patient population: results of a multicenter retrospective study. Malignant tumours. 2019;9(3):20-30. (In Russ.) https://doi.org/10.18027/2224-5057-2019-9-3-20-30

This work is licensed under a Creative Commons Attribution 4.0 License.

ISSN 2224-5057 (Print)
ISSN 2587-6813 (Online)

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Malignant tumours

Toxicity and efficacy of gemcitabine plus nab-paclitaxel (paclitaxel + albumin) in a Russian patient population: results of a multicenter retrospective study

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Abstract

Keywords

About the Authors

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