Chronic adverse effects after axillary lymphadenectomy in breast cancer patients after weaker and stronger postoperative analgesia: Results of a prospective double-blind randomized study.

e23066 Background: Tramadol is commonly used for pain treatment, but it is not known if stronger postoperative analgesia has an effect on chronic adverse effects in breast cancer patients. The aim of this study was to compare the rate of chronic adverse effects after weaker and stronger postoperative analgesia. Methods: A prospective double-blind randomized study included 118 breast cancer patients receiving tramadol for pain relief after axillary lymphadenectomy from 2015 to 2018 (Study EUDRA CT: 2015-000992-28). All patients used one of two analgesic regimens for 4 weeks after lymphadenectomy. Patients with larger dose received 75/650 mg of tramadol with paracetamol every 8 hours and a group with lower dose received 37.5/325 mg of tramadol with paracetamol every 8 hours. All patients received for four weeks twice daily naproxen sodium 550 mg and once a day pantoprazole 20 mg. One year after surgery patients were evaluated for the presence of neuropathic pain, chronic pain, arm symptoms and lymphedema. The association between dose of tramadol and chronic postoperative adverse effects was evaluated using asymptotic z-test and chi-square test. Results: Neuropathic pain was more common one year in comparison to one month after lymphadenectomy (p = 0.0001). There was a trend for lower rate of neuropathic pain after stronger analgesia in comparison to weaker analgesia (p = 0.058). Chronic pain was present in 18% of patients one year after lymphadenectomy. There was no difference in rate of chronic pain after stronger and weaker postoperative analgesia. Patients had less arm symptoms after stronger analgesia than after weaker analgesia (p = 0.02). Furthermore, there was a trend for lower rate of lymphedema of forearm after stronger analgesia than after lower analgesia (p = 0.078). Conclusions: The patients who received stronger postoperative analgesia had a statistical trend for less often neuropathic pain in comparison to patients who received weaker analgesia. The patients who received stronger postoperative analgesia had less arm symptoms and better quality of life in comparison to patients who received weaker analgesia. Clinical trial information: EudraCT 2015-000992-28.

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Chronic adverse effects after an axillary lymphadenectomy in breast cancer patients after administering weaker and stronger postoperative analgesia: results of a prospective double-blind randomized study

Breast Cancer Research and Treatment ◽

10.1007/s10549-020-05713-3 ◽

2020 ◽

Vol 182 (3) ◽

pp. 655-663

Author(s):

Nikola Besic ◽

Jaka Smrekar ◽

Branka Strazisar

Keyword(s):

Breast Cancer ◽

Adverse Effects ◽

Cancer Patients ◽

Postoperative Analgesia ◽

Randomized Study ◽

Breast Cancer Patients ◽

Double Blind ◽

Axillary Lymphadenectomy

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Acute pain and side effects after tramadol in breast cancer patients: results of a prospective double-blind randomized study

Scientific Reports ◽

10.1038/s41598-020-75961-2 ◽

2020 ◽

Vol 10 (1) ◽

Author(s):

Nikola Besic ◽

Jaka Smrekar ◽

Branka Strazisar

Keyword(s):

Breast Cancer ◽

Side Effects ◽

Cancer Patients ◽

Acute Pain ◽

Randomized Study ◽

Double Blind Study ◽

Breast Cancer Patients ◽

Dose Frequency ◽

Double Blind ◽

Axillary Lymphadenectomy

Abstract The objective of this study was to evaluate the severity of acute pain and side effects in breast cancer patients postoperatively treated with two regimens of tramadol with paracetamol in a prospective double-blind study. Altogether 117 breast cancer patients who had axillary lymphadenectomy were randomized into two analgesic study groups and the analgesic treatment lasted 4 weeks. Stronger analgesia group received every 8 h 75/650 mg of tramadol with paracetamol, while weaker analgesia group received every 8 h 37.5/325 mg of tramadol with paracetamol. Patients with the higher dose of tramadol had less pain during the 1st and 4th week than patients with the lower dose. Frequency of nausea, vomiting, lymphedema or range of shoulder movement was not significantly different between the two groups of patients. Constipation was significantly more common in the group with stronger analgesia during the 2nd week in comparison to patients with weaker analgesia. The patients who were on 75/650 mg of tramadol with paracetamol had less pain in comparison to patients who were on 37.5/325 mg. Side effects were mild, but common in both groups of patients.

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Association of OPRM1, MIR23B, and MIR107 genetic variability with acute and chronic pain after postoperative tramadol treatment in breast cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e24052 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e24052-e24052

Author(s):

Nikola Besic ◽

Katja Goricar ◽

Zala Vidic ◽

Branka Strazisar ◽

Vita Dolzan

Keyword(s):

Breast Cancer ◽

Chronic Pain ◽

Neuropathic Pain ◽

Pain Management ◽

Genetic Variability ◽

Cancer Patients ◽

Genetic Factors ◽

Axillary Lymph ◽

Breast Cancer Patients ◽

Wild Type

e24052 Background: Tramadol is an opioid analgesic often used for pain management after axillary lymph node dissection in breast cancer. It exerts its analgesic activity through activation of the G protein-coupled µ-opioid receptor, encoded by the OPRM1 gene. Genetic factors that may modify activity or expression of OPRM1 could thus affect the efficacy of tramadol treatment. This study investigated the association of genetic variability of OPRM1 and genes coding for miRNAs regulating OPRM1 expression with pain management in breast cancer patients treated with tramadol after surgery. Methods: The study included 113 breast cancer patients treated with either 75 or 37.5 mg of tramadol for pain relief after breast cancer surgery within the randomized clinical trial KCT 04/2015-DORETAonko/si at Institute of Oncology Ljubljana. All patients were genotyped for OPRM1 rs1799971 and rs677830, MIR23B rs1011784 and MIR107 rs2296616 using competitive allele-specific PCR. The association of genetic factors with acute and chronic pain was evaluated using logistic regression, Fisher’s exact test and Mann-Whitney test. Results: The investigated OPRM1 related genetic factors were not associated with acute pain measured using VAS scale within four weeks after surgery, even after adjustment for tramadol dose (all P > 0.05). One year after surgery, 21 (21.1%) patients experienced chronic pain and 25 (25.3%) experienced neuropathic pain. In carriers of two polymorphic MIR107 rs2296616 alleles, chronic pain was significantly more common compared to carriers of two wild-type alleles (35.3% compared to 0% of patients, P = 0.004). Carriers of at least one polymorphic MIR23B rs1011784 allele experienced more neuropathic pain compared to carriers of two wild-type alleles after adjustment for tramadol dose (OR = 2.85, 95% CI = 1.07-7.59, P = 0.036). Conclusions: Genetic variability of miRNAs that could affect OPRM1 expression may be associated with chronic pain in breast cancer patients treated with postoperative tramadol.

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Interleukin-10 Levels are Associated with Doxorubicin-Related Cardiotoxicity in Breast Cancer Patients in a One-Year Follow-Up Study

Immunological Investigations ◽

10.1080/08820139.2021.1882486 ◽

2021 ◽

pp. 1-16

Author(s):

Michelle Teodoro Alves ◽

Ricardo Simões ◽

Rodrigo Mendonça Cardoso Pestana ◽

Angélica Navarro de Oliveira ◽

Heloísa Helena Marques Oliveira ◽

...

Keyword(s):

Breast Cancer ◽

Cancer Patients ◽

Interleukin 10 ◽

Breast Cancer Patients ◽

Follow Up Study ◽

One Year

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Trastuzumab-Associated Cardiac Adverse Effects in the Herceptin Adjuvant Trial

Journal of Clinical Oncology ◽

10.1200/jco.2006.09.1611 ◽

2007 ◽

Vol 25 (25) ◽

pp. 3859-3865 ◽

Cited By ~ 378

Author(s):

Thomas M. Suter ◽

Marion Procter ◽

Dirk J. van Veldhuisen ◽

Michael Muscholl ◽

Jonas Bergh ◽

...

Keyword(s):

Breast Cancer ◽

Adjuvant Chemotherapy ◽

Adverse Effects ◽

Cancer Patients ◽

Cardiac Dysfunction ◽

Left Ventricular ◽

Left Ventricular Ejection ◽

Breast Cancer Patients ◽

Ventricular Ejection Fraction ◽

Neo Adjuvant Chemotherapy

Purpose The purpose of this analysis was to investigate trastuzumab-associated cardiac adverse effects in breast cancer patients after completion of (neo)adjuvant chemotherapy with or without radiotherapy. Patients and Methods The Herceptin Adjuvant (HERA) trial is a three-group, multicenter, open-label randomized trial that compared 1 or 2 years of trastuzumab given once every 3 weeks with observation in patients with HER-2–positive breast cancer. Only patients who after completion of (neo)adjuvant chemotherapy with or without radiotherapy had normal left ventricular ejection fraction (LVEF ≥ 55%) were eligible. A repeat LVEF assessment was performed in case of cardiac dysfunction. Results Data were available for 1,693 patients randomly assigned to 1 year trastuzumab and 1,693 patients randomly assigned to observation. The incidence of trastuzumab discontinuation due to cardiac disorders was low (4.3%). The incidence of cardiac end points was higher in the trastuzumab group compared with observation (severe congestive heart failure [CHF], 0.60% v 0.00%; symptomatic CHF, 2.15% v 0.12%; confirmed significant LVEF drops, 3.04% v 0.53%). Most patients with cardiac dysfunction recovered in fewer than 6 months. Patients with trastuzumab-associated cardiac dysfunction were treated with higher cumulative doses of doxorubicin (287 mg/m2 v 257 mg/m2) or epirubicin (480 mg/m2 v 422 mg/m2) and had a lower screening LVEF and a higher body mass index. Conclusion Given the clear benefit in disease-free survival, the low incidence of cardiac adverse events, and the suggestion that cardiac dysfunction might be reversible, adjuvant trastuzumab should be considered for treatment of breast cancer patients who fulfill the HERA trial eligibility criteria.

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