Research ArticleClinical Studies

Influence of the Coronavirus Disease 2019 Vaccine on Drug Therapy for Urological Cancer

SHOHEI KAWAGUCHI, KOUJI IZUMI, SUGURU KADOMOTO, HIROAKI IWAMOTO, HIROSHI YAEGASHI, MASASHI IIJIMA, TAKAHIRO NOHARA, KAZUYOSHI SHIGEHARA, YOSHIFUMI KADONO and ATSUSHI MIZOKAMI
Anticancer Research April 2022, 42 (4) 2105-2111; DOI: https://doi.org/10.21873/anticanres.15692

Abstract

Background/Aim: We investigated whether coronavirus disease 2019 (COVID-19) vaccination and its adverse events would cause cancer treatment of patients with urological cancer to be postponed or changed. Patients and Methods: We collected COVID-19 vaccination information including adverse events from the medical records of 214 patients with urological cancer receiving cancer drug therapy. Results: The cancer types were renal cancer in 40 cases (18.7%), upper urinary tract cancer in 10 cases (4.7%), bladder cancer in 21 cases (9.8%), prostate cancer in 140 cases (65.4%), and others in 3 cases (1.4%). Of the 214 patients, 178 (83.2%) had received the second dose of the vaccine. Out of 180 vaccinated patients, some adverse events were observed in 69 (38.3%). Vaccination rates for males and females were 85.4% (169/198) and 68.8% (11/16), respectively, and were not significantly different (p=0.081). The incidence of adverse events was significantly higher in females [72.7% (8/11)] than in males [36.1% (61/169)]; p=0.015. Treatment was modified in 11 vaccinated patients; postponed or changed at the discretion of the attending physician in 8 cases, skipped at the discretion of the patient in 1 case, and postponed due to side effects of the immune checkpoint inhibitor in 1 case. Treatment for one patient with upper urinary tract cancer on pembrolizumab was postponed for three weeks due to adverse events of the vaccine. Conclusion: Only 0.6% of the adverse events of the vaccine required postponement of treatment, suggesting that vaccination is safe even during cancer drug therapy.

Key Words:

The coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has been spreading worldwide since December 2019 (1). As of September 26, 2021, 231 million cases of COVID-19 and 4.74 million deaths have been reported worldwide (2). In Japan, the first patient with COVID-19 was reported on January 15, 2020 (3).

On February 14, 2021, the Pfizer/BioNTech vaccine was approved for use in Japan, as well as that of Moderna and Oxford/AstraZeneca on March 21, 2021. In Japan, the use of the Oxford/AstraZeneca vaccine is limited to people who are allergic to other vaccines, and most people have been vaccinated with the Pfizer/BioNTech or Moderna vaccine. The Pfizer/BioNTech and Moderna vaccines were reported to have a 95% and 94.1% effectiveness in preventing COVID-19, respectively (4, 5). Both vaccines, which are mRNA vaccines, have been shown to cause transient local and systemic adverse events in several cases.

Patients with cancer and COVID-19 have been reported to deteriorate into severe illness more likely than those without cancer (6). Moreover, patients who recently received cytotoxic chemotherapy, which can lead to lymphocyte reduction, have been reported to have poor prognosis and prolonged periods of viral shedding (3). Thus, COVID-19 can lead to postponement of treatment and worsening of outcome in patients with cancer, therefore prevention by vaccination is highly important. It has also been reported that patients over 60 years old are significantly more likely to have severe infection (7). Urological cancers are more common in the elderly, and the risk of severe COVID-19 is likely to be higher, thus more attention is needed. However, there is insufficient knowledge about the effects and safety of vaccination in patients with urological cancer.

We performed a retrospective study on the influence of the COVID-19 vaccine on Japanese patients with urological cancer undergoing cancer drug therapy. We investigated whether COVID-19 vaccination and its adverse events would cause cancer drug therapy to be postponed, changed, or discontinued.

Patients and Methods

Patients with urological cancer who had received cancer drug therapy at Kanazawa University Hospital between February 2021 and September 2021 were retrospectively evaluated. COVID-19 vaccination status and the presence of adverse events were collected from medical records. We excluded patients with no data on vaccination status or adverse events. We equally collected patient demographics, oncological characteristics, and details of cancer treatment. In Japan, elderly people aged 65 years or older were given priority for vaccination, thus we investigated vaccination rates and adverse event rates separately for those aged 65 years or older and those under 65 years. We also investigated the rate of vaccination and the incidence of adverse events according to sex, stage of cancer (stage 4 or not, presence or absence of distant metastasis, presence or absence of lymph node metastasis, T stage 3 or higher or not), and cancer type. We investigated whether cancer drug treatment around vaccination was changed or postponed. Comparisons between groups were performed by Fisher’s exact test. All data analyses were performed using SPSS for windows (SPSS Inc., Chicago, IL, USA), and a p-value of <0.05 was considered to indicate statistical significance. This study was approved by the institutional review board of Kanazawa University Hospital (2021-035). Patient consent was obtained through an opt-out on the website.

Results

COVID-19 vaccination information including adverse events was collected from the medical records of 214 patients with urological cancer on cancer drug therapy. Table I shows the demographics and cancer states of the patients. The median age was 73 years, and 92.5% of the patients were male. The median age of males and females was 72 and 73 years, respectively. The cancer types were renal cancer in 40 cases (18.7%), upper urinary tract cancer in 10 cases (4.7%), bladder cancer in 21 cases (9.8%), prostate cancer in 140 cases (65.4%), urethral cancer in 1 case (0.5%), and neuroendocrine cancer in 2 cases (0.9%). Table II shows the details of cancer drug therapy. Thirty-six patients received immune checkpoint inhibitors, 17 patients received systemic chemotherapy, 24 patients received molecular targeted therapy, 140 patients received hormonal therapy, and 6 patients received intravesical infusion therapy. Bone modifying agents (BMA) were used in 28 patients, denosumab in 18 and zoledronic acid in 10.

View this table:
Table I.

Patient characteristics.

View this table:
Table II.

Details of the treatment.

Of the 214 patients, 180 (84.1%) had received the first dose of the vaccine, and 178 (83.2%) had received the second dose. Figure 1 shows the adverse events of vaccination. Out of 180 vaccinated patients, some adverse events were observed in 69 (38.3%). Pain at the injection site was the most common symptom (22.8%), followed by fever at 37.5°C (10.0%) or higher and muscle pain (10.0%). The vaccination rate among those aged 65 years and older was 86.3% (151/175), whereas that among those under 65 years was 74.4% (29/39) (p=0.088) (Figure 2). Vaccination rates for males and females were 85.4% (169/198) and 68.8% (11/16), respectively, and were not significantly different (p=0.144). The incidence of adverse events in patients older than 65 years and younger than 65 years was 35.8% (54/151) and 51.7% (15/29), respectively (p=0.144). The incidence of adverse events was significantly higher in women [72.7% (8/11)] than in men [36.1% (61/169)]; p=0.023.

Figure 1.
Figure 1.

Incidence of adverse events in urological cancer patients undergoing cancer drug therapy.

Figure 2.
Figure 2.

Vaccination rate and incidence of adverse events by age, sex, cancer stage, distant metastasis, lymph node metastasis, and local progression.

Vaccination rates among patients with prostate cancer, renal cancer, and upper and lower urinary tract cancer were 92.1% (129/140), 67.5% (27/40), and 68.7% (22/32), respectively, with adverse reaction rates of 29.5% (38/129), 55.6% (15/27), and 59.1% (13/22), respectively. Vaccination rate was significantly higher (p<0.001) while adverse event was significantly lower (p=0.001) in prostate cancer patients compared to patients with other cancer types.

The vaccination rate among patients with stage 4 cancer was 78.9% (112/142), which was significantly lower than the vaccination rate of 94.4% (68/72) among patients with stage 3 cancer or lower (p=0.003). Vaccination rate was significantly lower in patients with distant metastasis [79.2% (95/120)] than in patients without distant metastasis [90.4% (85/94)] (p=0.037). Vaccination rate was significantly lower in patients with lymph node metastasis [78.1% (75/96)] compared to patients without lymph node metastasis [89.0% (105/118)] (p=0.038). The vaccination coverage of patients with T stage 3 or higher was 82.0% (110/134), which was not significantly different from that of patients with stage 2 or lower [87.5% (70/80)] (p=0.338).

The incidence of adverse events in patients with stage 4 disease was 40.2% (45/112), which was not significantly different from the incidence of adverse reactions in patients with stage 3 disease or less [35.3% (24/68)] (p=0.532). The incidence of adverse events in patients with distant metastases was 41.1% (39/95), which was not significantly different from the incidence of adverse events in patients without distant metastases [35.3% (30/85)] (p=0.447). The incidence of adverse events in patients with lymph node metastases was 33.3% (25/75), which was not significantly different from the incidence of adverse events in patients without lymph node metastases [41.9% (44/105)] (p=0.278). The incidence of adverse events in patients with T stage 3 or higher was 38.2% (42/110), which was not significantly different from the incidence of adverse events in patients with T stage 2 or lower [38.6% (27/70)] (p=1.000).

Treatment was postponed or changed in 11 vaccinated patients (6.1%) (Table III); they all did not receive BMA. In two patients with renal cancer who were on nivolumab, and one patient with neuroendocrine cancer who was on pembrolizumab, treatment was postponed for one week and two weeks, respectively, during the vaccination period, at the discretion of the attending physician. In one patient with renal cancer who was taking axitinib, the oral administration was skipped for several days around the vaccination period at the patient’s own discretion. In two patients with bladder cancer receiving Bacillus Calmette–Guerin (BCG) intravesical instillation therapy, infusion was postponed for one week during the vaccination period at the discretion of the attending physician. In two patients with bladder cancer who were undergoing intravesical injection of pilarubicin, injection was postponed for one week during the vaccination period at the discretion of the attending physician. The treatment of one patient with prostate cancer undergoing docetaxel and androgen depletion therapy was changed from docetaxel to ethinyl estradiol during the vaccination period at the discretion of the attending physician. The treatment of one patient with upper urinary tract cancer receiving pembrolizumab was postponed for three weeks due to adverse events of the vaccine. The patient reported fever above 37.5°C, pain at the injection site, fatigue, headache, muscle pain, and loss of appetite. Pembrolizumab could be continued after three weeks of withdrawal. One patient with upper urinary tract cancer on pembrolizumab had an adverse event of pembrolizumab (adrenocorticotropic hormone deficiency alone) concurrently with vaccination. The patient’s treatment could be resumed without disease progression although the patient needed pembrolizumab withdrawal for 15 weeks.

View this table:
Table III.

Change or postponement of treatment due to vaccination.

Discussion

COVID-19 has been spreading worldwide since December 2019, and the World Health Organization declared the COVID-19 pandemic on March 11, 2020 (8). Responding to this pandemic has become one of the most important global issues because of the direct health damage caused by SARS-CoV-2 and the socioeconomic burden caused by behavior restrictions (9). Vaccines have been developed as a means of combating the COVID-19 pandemic, and vaccination is now underway globally (4, 5). Vaccine breakthrough infections with SARS-CoV-2 variants and some problems with the COVID-19 vaccine, such as breakthrough infections and post-mRNA vaccine myocarditis (10, 11), have been pointed out, and additional validation for efficacy and safety is needed.

In the COVID-19 era, many hospitals have limited elective surgeries in order to prevent COVID-19 infections and only allow surgeries necessary for survival of the patient with cancer (12). COVID-19 has a negative impact on the treatment of many diseases, including cancer. Cancer itself is a risk for COVID-19 severity (6), and its prevention is of great importance. Responding to this pandemic has become one of the most important global issues because of the direct health damage caused by SARS-CoV-2 and the socioeconomic burden caused by behavior restrictions (9). Adopting effective preventive strategies requires evidence-based identification of population groups at risk and patient stratification based on individualized profiling (13). Although several reports have described the effects of COVID-19 on patients with cancer, the evidence is still insufficient, including the effects of vaccination. In practice, the proportion of patients with cancer included in clinical trials of COVID-19 vaccines was low (3.7%) (4), thus, the safety of COVID-19 vaccines in patients with cancer is unknown.

It has been reported that while about half of the patients with cancer accept COVID-19 vaccination, a relatively high proportion of patients with cancer are resistant to vaccination (28.3%), suggesting that concerns about cancer outcomes and vaccine safety may cause vaccination hesitancy (14). It has been pointed out that misinformation on the Internet and social media may discourage people from getting vaccinated (15). In this study, the vaccination rate was significantly lower in patients with advanced cancer. However, there was no significant difference in adverse events due to the vaccine between patients with early-stage cancer and those with advanced cancer. This suggests that patients with advanced cancer undergoing drug therapy can be safely vaccinated as patients with early-stage cancer. In effect, one study reported that patients with cancer could be vaccinated with minimal serious adverse events (16). It is important to accumulate evidence on the safety of COVID-19 vaccine in patients with cancer and to disseminate correct information.

In the present study, we investigated COVID-19 vaccination status, incidence of adverse events, and whether treatment was postponed or changed due to adverse events of the vaccine in Japanese patients with urological cancer undergoing cancer drug therapy. As of September 30, 2021 in Japan, the two-dose vaccination rate was 55.2%, and the vaccination rate for people aged 65 years and older was 89.5% (17). The vaccination rate among patients with urological cancer on drug therapy was 84.1%, and that of the patients over 65 years old was 86.3%. Vaccination rates in patients aged 65 years and older were comparable to those in the general population aged 65 years and older. The high vaccination rate at all ages in this study may be due to the fact that urological cancers are more common in the elderly.

It was reported that about 90% of those who received the mRNA COVID-19 vaccine experienced some kind of adverse event, the most common being pain at the injection site, followed by fatigue and headache (18, 19). The incidence of adverse events in this study was low at 38.3%. In an age-specific study of the adverse events of the mRNA COVID-19 vaccine, it was reported that 77% of people over 80 years of age did not complain of either local or systemic symptoms (20). It has also been reported that adverse reactions to the mRNA COVID-19 vaccine are more common in females than in males (20). The low incidence of adverse reactions in the present study may have been due to the large number of elderly men. Another possibility is that there was some interval between the vaccination and the doctor’s visit, which may have led to underreporting of adverse events. In this study, the rate of vaccination was higher, whereas the incidence of adverse events was lower in patients with prostate cancer than that in patients with other cancer types. This may be attributed to the higher proportion of young adults and women with other cancer types as compared with prostate cancer.

In the present study, drug therapy was postponed or changed in 11 cases (6.1%). Of these, treatment was postponed or changed at the physician’s discretion in 7 patients (63.6%) and 1 patient (9.1%), respectively, and medication was skipped at the patient’s discretion in 1 patient (9.1%). Treatment was postponed due to side effects of immune checkpoint inhibitors in 1 patient (9.1%). Only 1 patient (0.6%) required postponement of cancer drug therapy due to an adverse event of vaccination. This suggests that vaccination can be administered safely to patients with urological cancer undergoing cancer drug therapy, as in the general population, with limited impact on treatment.

The limitations of the study were its retrospective nature and the small sample size. Of the subjects, more than half were patients with prostate cancer, and among the cancer drug therapy, there was a bias for hormonal therapy. Because this study was based on outpatient medical records, we were not able to fully investigate patients undergoing inpatient treatment (e.g., cisplatin-based chemotherapy), and the proportion of patients receiving chemotherapy for urothelial carcinoma may have been small. Because the medical records did not accurately record whether the Pfizer/BioNTech or Moderna vaccine was administered, it was not possible to examine the vaccine by type.

In the present study, we investigated the effects of the mRNA COVID-19 vaccination on patients with urinary cancer on drug therapy. Only 0.6% of the side effects of the vaccine required postponement of treatment, suggesting that vaccination is safe even during cancer drug therapy. In the future, it will be necessary to confirm the safety of vaccines in larger-scale studies and provide appropriate information to patients with cancer.

Acknowledgements

The Authors would like to thank Enago (www.enago.jp) for the English language review.

Footnotes

  • Authors’ Contributions

    Study conception and design: Kouji Izumi, Shohei Kawaguchi. Acquisition of data: Suguru Kadomoto, Hiroaki Iwamoto, Hiroshi Yaegashi, Masashi Iijima, Shohei Kawaguchi, Takahiro Nohara, Kazuyoshi Shigehara, Kouji Izumi, Yoshifumi Kadono. Analysis and interpretation of data: Shohei Kawaguchi, Takahiro Nohara, Kazuyoshi Shigehara, Kouji Izumi, Yoshifumi Kadono. Drafting of the manuscript: Shohei Kawaguchi. Project supervision: Atsushi Mizokami.

  • Conflicts of Interest

    There are no financial or other relations that could lead to a conflict of interest regarding this study.

  • Received January 20, 2022.
  • Revision received February 11, 2022.
  • Accepted February 14, 2022.

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Influence of the Coronavirus Disease 2019 Vaccine on Drug Therapy for Urological Cancer
SHOHEI KAWAGUCHI, KOUJI IZUMI, SUGURU KADOMOTO, HIROAKI IWAMOTO, HIROSHI YAEGASHI, MASASHI IIJIMA, TAKAHIRO NOHARA, KAZUYOSHI SHIGEHARA, YOSHIFUMI KADONO, ATSUSHI MIZOKAMI
Anticancer Research Apr 2022, 42 (4) 2105-2111; DOI: 10.21873/anticanres.15692
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