Research ArticleClinical Studies

Comparison of Quality of Life and Injection Site Reactions After Switching from Degarelix 80 mg to 480 mg in Advanced Prostate Cancer: A Prospective Trial

KEIICHIRO MIYAJIMA, TAKAFUMI YANAGISAWA, HIROTAKA SUZUKI, WATARU FUKUOKAYA, KEIGO SAKANAKA, KOKI OBAYASHI, JUN MIKI and TAKAHIRO KIMURA
Anticancer Research April 2023, 43 (4) 1611-1621; DOI: https://doi.org/10.21873/anticanres.16311

Abstract

Background/Aim: Degarelix has been widely used for prostate cancer; however, injection site reactions (ISRs) can be a clinical issue. We assessed differences in ISR intensity and patient quality of life (QOL) between degarelix 80 mg and 480 mg, a three-month formulation launched in 2020 in Japan. Patients and Methods: We prospectively analyzed 25 patients with advanced prostate cancer. ISR intensity and patient QOL were evaluated before and after switching from degarelix 80 mg to 480 mg. A visual analogue scale (VAS) and faces rating scale (FRS) were applied to assess the ISRs. We applied a rating format from the M. D. Anderson Symptom Inventory (MDASI) to assess patient QOL. Results: For degarelix 80 mg and a first dose of 480 mg, the incidence rate of ISRs was 84% and 92%, respectively (p=0.083). ISR pain on the third day after injection scored by VAS was 2.7±2.8 and 5.2±2.7, respectively (p<0.001). Other ISR findings such as redness, induration, swelling, warmth, and itching were significantly worse for degarelix 480 mg than for 80 mg. In the category of patient QOL, interference with activities of daily living such as general activity was significantly worse after degarelix 480 mg (p=0.003). However, 80% of patients were able to continue degarelix 480 mg during the nine months of follow-up. Conclusion: Degarelix 480 mg seems to exacerbate pain and other ISR findings, and to reduce patient QOL, compared with degarelix 80 mg. Optimal management of ISRs is essential to maintain patient QOL when using degarelix 480 mg.

Key Words:

Degarelix, a third-generation gonadotropin-releasing hormone (GnRH) antagonist, which induced significantly faster reduction of testosterone to castration levels without testosterone surge, is now widely used for the treatment of prostate cancer (PCa) (1-3). In comparison with GnRH agonists, a phase III study comparing degarelix with the GnRH agonist Leuprolide showed that degarelix immediately and significantly decreased the level of serum testosterone, follicle-stimulating hormone (FSH), luteinizing hormone (LH), and prostate-specific antigen (PSA), which improved PSA-progression-free survival (4). In addition, a recent meta-analysis reported that degarelix was associated with lower overall mortality rates and fewer cardiovascular events than GnRH agonists (5). However, they mentioned that degarelix was associated with a higher rate of injection site reactions (ISRs) (38%) than the agonists (4.8%) (5).

ISRs, including pain, redness, swelling, and warmth, are sometimes clinical issues that negatively affect patient QOL. In a Japanese phase II study comparing degarelix 80 mg and 160 mg as a maintenance dose, 48% of the patients treated with degarelix experienced ISRs (6). However, most of the ISRs were less than Grade 2 as defined by the Common Terminology Criteria for Adverse Events (CTCAE), and only 2.2% of patients treated with degarelix 160 mg discontinued treatment due to ISRs during one-year follow-up (6).

In Japan, a three-month formulation of degarelix 480 mg was launched in January 2020 and is covered by health insurance for clinical practice. In a Japanese phase III study comparing degarelix 480 mg with goserelin 10.8 mg, the most frequent adverse events in the degarelix 480 mg group were ISRs such as pain (75.2%), erythema (69.2%), and induration (65.8%) (7). These findings indicate a generally higher incidence of ISRs for degarelix 480 mg than for degarelix 80 mg.

However, there were no data regarding a direct comparison of the degree of ISRs between degarelix 80 mg and 480 mg as a maintenance dose. Since a higher incidence of ISRs may affect patient QOL, we designed a study to assess the impact of switching from degarelix 80 mg to 480 mg on ISRs and patient QOL in patients with metastatic or advanced PCa. Our assessment was based on patient-reported outcomes.

Patients and Methods

Study design and patient selection. This investigation was designed as a prospective, single-arm, observational study with approval by the Ethics Committee of the Jikei University School of Medicine, Tokyo, Japan [32-022(10097)]. We prospectively evaluated 28 PCa patients who were treated with degarelix 80 mg as a maintenance dose of a primary Androgen-deprivation therapy (ADT) and planned to switch to 480 mg between January 2019 and April 2020 at Jikei University Kashiwa Hospital, Chiba, Japan. We excluded three patients who died from PCa during the study; the remaining 25 patients were eligible for analysis. The study enrolled patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1. The primary end-point of the present study was the difference in the degree of ISRs using visual analogue scale (VAS), the faces rating scale (FRS), and patient QOL during the month after injection, comparing degarelix 80 mg and 480 mg as a first dose. The difference in these outcomes between degarelix 80 mg and 480 mg as a second dose was also evaluated.

Subcutaneous injection method of degarelix and follow-up protocol. After sufficient cooling, degarelix 80 mg or 480 mg was injected subcutaneously for 30 seconds at an angle of 45 degrees in the abdomen. No medication was prescribed before injection. However, for patients who had suffered from symptoms caused by first injection of degarelix 480 mg, painkillers, and/or prophylactic antipyretics, and/or antiemetics were prescribed after second injection of degarelix 480 mg. Degarelix 80 mg was injected alternatively in the left or right abdomen, and degarelix 480 mg was injected in both the left and right abdomen. Injection was avoided at previous sites of induration and in regions that would be covered by a belt. For degarelix 480 mg, the side (left or right) showing the more intense ISRs was evaluated. Patients received medical check-ups and questionnaires. Patient condition was examined, and blood tests were performed every four weeks. We followed the included patients for nine months after switching to degarelix 480 mg and assessed the persistence rate during the follow-up periods.

Evaluation methods of ISRs and QOL. After obtaining informed consent, patients were switched from degarelix 80 mg to 480 mg. A questionnaire was distributed to evaluate the degree of ISRs and the patients’ QOL before and after switching. The degree of ISRs at three and seven days after injection were evaluated using a visual analogue scale (VAS) for the evaluation of pain. The faces rating scale (FRS) consisted of a five-grade evaluation (1-5) regarding redness, induration, swelling, warmth, and itching. We defined the minimum score on the VAS and FRS (VAS=0, FRS=1) as no pain or symptoms accompanied by ISRs. In addition, ISRs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute, version 5.0.

The rating format of the M. D. Anderson Symptom Inventory (MDASI) was used to assess patient QOL (8). We asked the patients about their MDASI score of the recent month, from injection to the next visit in four weeks. The MDASI consists of two-part questions: symptoms and interference with daily living caused by these symptoms. The 13 symptoms are those that patients found to occur most frequently and/or to be the most severe: pain, fatigue, nausea, disturbed sleep, feeling distressed, shortness of breath, difficulty remembering, lack of appetite, feeling drowsy, dry mouth, feeling sad, vomiting, and numbness or tingling. The interference items included general activity, emotional aspects, work, relations with other people, walking, and enjoyment of life on a scale of 0 to 10 (8).

Ethics approval. This study was approved by our institutional review board, No. 32-022(10097).

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Each patient was informed about the content of this study, and formal consent was obtained.

Statistical analysis. Continuous parametric variables were reported as mean±standard deviation (SD) or median [interquartile range (IQR)]. We regarded VAS, FRS and QOL scores as continuous parametric variables and used Student’s paired t-test to compare changes in scores. We applied Fisher’s exact test to compare the incidence of ISRs. Two-sided p<0.05 was considered to be statistically significant. All statistical analyses were performed with EZR (Saitama Medical Center, Jichi Medical University, Saitama, Japan) (9), which is a graphical user interface for R (The R Foundation for Statistical Computing, Vienna, Austria). More precisely, EZR is a modified version of R Commander designed to provide statistical functions frequently used in biostatistics.

Results

Patient demographics. Patient demographics at ADT initiation are shown in Table I. The median age was 75 (IQR=72-79), and the median body mass index (BMI) was 21 (IQR=20-23) kg/m2. ECOG-PS0 and PS1 rates were 92% and 8%, respectively. Twenty-four patients (96%) were administered ADT to treat metastatic hormone-sensitive PCa, of whom 21 were also treated with abiraterone and 3 with bicalutamide. The pathological evaluation showed 4 patients (16%) had a Gleason score (GS) of 7, 5 patients (20%) had GS of 8, and 16 patients (64%) had GS of 9 or higher. During nine months of follow-up, 5 patients (20%) discontinued degarelix 480 mg due to ISRs and switched to the LHRH agonist.

View this table:
Table I.

Patient demographics at initiation of androgen deprivation therapy.

The differences in pain and the other findings related to ISRs Comparison between degarelix 80 mg and 480 mg as first dose. The incidence rate of ISRs after administration of degarelix 80 mg and 480 mg as a first dose was 84% (21/25) and 92% (23/25), respectively (p=0.083). The rate of CTCAE Grade 2 was 81.0% and 100% in degarelix 80 mg and 480 mg as a first dose, respectively.

On the third day after injection, the mean VAS score was significantly better for degarelix 80 mg than for the first dose of degarelix 480 mg (2.7±2.8 and 5.2±2.7, respectively, p<0.001) (Table II, Figure 1). On the seventh day after injection, the VAS scores of both groups after injection were better than those on the third day after injection. However, the mean VAS score was also significantly different between the groups (80 mg: 1.0±2.1 vs. first dose of 480 mg: 3.2±2.6, p<0.001) (Table II, Figure 1).

View this table:
Table II.

Comparison of detailed findings for injection site reactions evaluated by visual analogue scale (VAS) and faces rating scale.

Figure 1.
Figure 1.

Injection site reactions comparison of degarelix 80 mg vs. 480 mg as a first dose at three and seven days after injection: pain (A), redness (B), induration (C), swelling (D), warmth (E), itching (F).

Regarding other detailed findings of ISRs evaluated by FRS, the first dose of degarelix 480 mg was significantly associated with more severe ISRs such as redness, induration, swelling, warmth and itching than for degarelix 80 mg on both the third and seventh day after injection (Table II, Figure 1). Overall, the results from VAS and FRS regarding all aspects of ISRs on both the third and seventh day after injection were significantly better for degarelix 80 mg.

Comparison between degarelix 80 mg and 480 mg as a second dose. When comparing degarelix 80 mg and degarelix 480 mg as a second dose, pain, redness, swelling, and warmth on the third day after injection were significantly less severe for degarelix 80 mg. There was no significant difference in induration and itching between degarelix 80 mg and 480 mg as a second dose (Table II).

A comparison of the first dose and second dose for degarelix 480 mg showed no significant differences in the incidence rate and severity of all ISRs between the groups (Figure 2).

Figure 2.
Figure 2.

Comparison of injection site reactions evaluated using visual analogue scale (VAS) and faces rating scale (FRS) for degarelix 80 mg, 480 mg as a first and second dose three days after injection: pain (A), redness (B), induration (C), swelling (D), warmth (E), itching (F).

QOL outcome evaluated by MDASI. Comparison between degarelix 80 mg and after 480 mg initiation

Table III shows the results of MDASI for 13 symptoms, with significant differences for pain (80 mg: 3.0±3.0 vs. 480 mg: 5.1±3.6 p=0.017) and feeling distressed (80 mg: 1.4±1.9 vs. 480 mg: 3.8±3.9 p=0.015). We found no significant difference in other symptoms (Figure 3).

View this table:
Table III.

Comparison of patients’ quality of life using M. D. Anderson Symptom Inventory.

Figure 3.
Figure 3.
Figure 3.

Comparison of symptom items evaluated by using the M. D. Anderson Symptom Inventory for degarelix 80 mg, 480 mg as first and second dose: pain (A), fatigue (B), nausea (C), disturbed sleep (D), feeling distressed (E), shortness of breath (F), difficulty remembering (G), lack of appetite (H), feeling drowsy (I), dry mouth (J), feeling sad (K), vomiting (L), numbness or tingling (M).

Assessment of symptoms interfering with activities of daily living showed a significant difference in patient life in the categories of general activity (80 mg: 1.4±2.2 vs. 480 mg: 2.6±3.0 p=0.003) (Table III, Figure 4).

Figure 4.
Figure 4.

Comparison of interference items evaluated by the M. D. Anderson Symptom Inventory for degarelix 80 mg and 480 mg as a first and second dose: general activity (A), emotional aspects (B), work (C), relations with other people (D), walking (E), enjoyment of life (F).

Comparison between degarelix 80 mg and after second dose of 480 mg. Compared with degarelix 80 mg and 480 mg as a second dose, we found significant differences in pain (80 mg: 3.0±3.0 vs. 480 mg as a second dose: 5.7±2.8 p=0.006), but no significant differences for feeling distressed (80 mg: 1.4±1.9 vs. 480 mg as a second dose: 2.4±3.0, p=0.385) or general activity (80 mg: 1.4±2.2 vs. 480 mg as a second dose: 2.8±3.2, p=0.057) (Table III).

In addition, comparing the first dose with the second dose for degarelix 480 mg, there were significant differences in fatigue (480 mg first dose: 1.9±2.6 vs. 480 mg second dose: 2.9±2.7 p=0.008) and difficulty remembering (480 mg first dose: 0.7±1.8 vs. 480 mg second dose: 1.3±1.8 p=0.015) (Figure 3) but no significant differences in interference with activities of daily living (Figure 4).

Management of ISRs for included patients. Among 25 patients, three patients required non-steroidal anti-inflammatory drugs (NSAIDs) as a painkiller, two patients required acetaminophen as a prophylactic antipyretic, and two patients required antiemetics. Despite the high rate of ISRs, 20 of 25 evaluable patients (80%) continued the administration of degarelix 480 mg with proper management for ISRs during the nine months of follow-up. There were no serious ISRs or ISRs leading to death.

Discussion

This prospective study revealed that the incidence of ISRs was 84% for degarelix 80 mg compared to 92% for the first dose of degarelix 480 mg. Two studies from Japan reported that the incidence of ISRs in degarelix 80 mg was approximately 50% (6, 10). Ozono et al. reported that the incidence of ISRs in degarelix 480 mg was up to 94.9% in a Japanese phase III study (7). In the present study, ISR incidence rates for both degarelix 80 mg and 480 mg were approximately equal or higher than previously reported. The primary reason for these results might be attributed to evaluating ISRs precisely from patient-reported outcomes.

In addition, our study first demonstrated that pain and other findings related to ISRs were significantly worse for degarelix 480 mg than for 80 mg. In addition, we found no difference in the incidence and degree of ISRs between the first and second dose of degarelix 480 mg. These results suggest that patients will probably not develop tolerance to ISRs during treatment with degarelix 480 mg.

On the other hand, the absence of precise definitions for both subjective and objective degrees of ISRs makes clinical assessment and comparison between studies challenging. CTCAE is widely used to evaluate adverse events in clinical trials and clinical practice, as well as to assess ISRs. CTCAE version 5 defines ISRs as follows: Grade 1: tenderness with or without associated symptoms (e.g., warmth, erythema, itching), Grade 2: pain, lipodystrophy, edema, phlebitis. Therefore, most ISRs are categorized as CTCAE Grade 2, as there is no clear definition of quantitative evaluation particularly regarding pain. For proper assessment and management of ISRs, the establishment of detailed definitions and categories is mandatory. In the present study, ISRs were evaluated by patient-reported outcomes using VAS and FRS scores. We believe that VAS and FRS scores might help in evaluating the CTCAE grading system, leading to proper management of ISRs in clinical practice.

The MDASI assessment system, which accounts for the majority of symptomatic distress reported by cancer patients, is well-known and helps to clarify the patients’ physical and emotional aspects of QOL (8). Our study revealed that initiation of degarelix 480 mg significantly exacerbated the pain score, consistent with the VAS scale findings shown above. Furthermore, symptoms that interfered with activities of daily living such as general activity were significantly worse after the initiation of degarelix 480 mg.

Maintaining patient QOL is a key factor in PCa treatment, since the prognosis for PCa is generally better than that for other malignancies (11). A study of patient preferences for CRPC treatment indicated that CRPC patients were more concerned about QOL in relation to adverse events of treatment than about extension of survival (12). A study from Europe, which focused on PCa with bone metastases, reported that patients were willing to sacrifice 3 to 5 months of survival in order to avoid bone complications (13). Thus, in addition to the benefit of prolonged survival, maintaining patient QOL is a key factor in optimal shared decision-making for patients with metastatic PCa who are suitable candidates for degarelix.

Our study showed significant differences in fatigue and difficulty remembering between the first and second doses of 480 mg. A recent meta-analysis reported that PCa patients who receive ADT have increased risk of dementia and/or Alzheimer disease, and this risk was more pronounced when ADT was given for longer than 12 months (14). Such effects, particularly on cognitive function due to the accumulation of degarelix, should be taken into account. Further study with long-term follow-up to assess this verification is warranted.

For lessening the effect of ISRs, it is generally said that injection should be avoided in areas easily exposed to pressure, such as the waistband and belt area or the ribs. In addition, slow injection at an angle of no less than 45 degrees, with cooling after injection, is said to be essential (15). Particularly for degarelix 480 mg, these measures seem to be necessary to reduce ISRs. However, other than injection methods, the optimal management to decrease ISR-related symptoms is still undetermined.

In this study, three patients used painkillers, two patients used prophylactic antipyretics, and two patients used antiemetics after the second dose of degarelix 480 mg. Hypothetically, these prescriptions enabled those patients to continue degarelix 480 mg, leading to high persistence rate. Furthermore, our results showed that the values of feeling distressed after the second dose were lower than those after the first dose of degarelix 480 mg. Such findings suggest that appropriate management of ISRs can help maintain patient QOL and thus allow patients to persist in their use of degarelix 480 mg.

This study has several limitations that need to be considered. First, the number of patients was limited. Second, we assessed patient QOL by evaluating differences between degarelix 80 mg and 480 mg for one month after injection (not during the entire three months after degarelix 480 mg injection), which could have caused patient QOL to be underestimated. Finally, painkillers and so on were prescribed after the second injection at some patients, therefore it might have influenced the results of QOL.

However, our study is the first to evaluate differences in the incidence of ISRs, pain, and patient QOL between degarelix 80 mg and 480 mg as a maintenance dose using patient-reported outcomes.

We found in our prospective study that pain, and other findings related to ISRs were significantly worse in patients treated with degarelix 480 mg than with degarelix 80 mg as a maintenance dose. Furthermore, severe ISRs appear to decrease patient QOL in areas such as feeling distressed and general activity. However, the majority of patients continued to use degarelix 480 mg with or without appropriate medications for ISRs. Optimal assessment and management for ISRs is essential to maintain patient QOL when using degarelix 480 mg.

Footnotes

  • Authors’ Contributions

    KM and TY contributed to protocol/project development, data collection and management, data analysis, and manuscript writing/editing. TK contributed to protocol/project development and manuscript editing. HS, WF, KS, and KO contributed to data collection. JM contributed to manuscript editing.

  • Conflicts of Interest

    Takahiro Kimura is a paid consultant/advisor of Astellas, Bayer, Janssen and Sanofi. The other Authors have no conflicts of interest to declare in relation to this study.

  • Received January 4, 2023.
  • Revision received January 16, 2023.
  • Accepted January 17, 2023.

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Comparison of Quality of Life and Injection Site Reactions After Switching from Degarelix 80 mg to 480 mg in Advanced Prostate Cancer: A Prospective Trial
KEIICHIRO MIYAJIMA, TAKAFUMI YANAGISAWA, HIROTAKA SUZUKI, WATARU FUKUOKAYA, KEIGO SAKANAKA, KOKI OBAYASHI, JUN MIKI, TAKAHIRO KIMURA
Anticancer Research Apr 2023, 43 (4) 1611-1621; DOI: 10.21873/anticanres.16311
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