Comparison of tolerability and adverse events following treatment with two GnRH agonists in patients with advanced prostate cancer.
Key Words: Androgen deprivation therapy, GnRH agonist, injection site pain, injection, intramuscular injection, subcutaneous injection.
Prostate cancer is the second most common cancer in men and the second leading cause of deaths from cancer in men in the United States (American Cancer Society [ACS], 2013). The incidence of prostate cancer has been decreasing since 2004 in men 65 years of age or older, but it has remained stable in men younger than 65 years of age. The estimated number of new cases in 2013 is 238,590, and the estimated number of deaths is 29,720. Treatment options vary depending on patient age and cancer stage and grade.
In patients with advanced disease, treatment options may include hormonal therapy, chemotherapy, and radiation (ACS, 2013). However, androgen deprivation therapy, including treatment with gonadotropin-releasing hormone (GnRH) agonists, is the recommended therapy for the palliative treatment of advanced prostate cancer (National Comprehensive Cancer Network [NCCN], 2013). These medications are delivered by intramuscular (IM) or subcutaneous (SC) injections, which have been associated with injection site reactions and other tolerability issues. Leuprolide acetate (Eligard[R]) and triptorelin pamoate (Trelstar[R]) are two such GnRH agonists indicated for the palliative treatment of advanced prostate cancer. Leuprolide is administered subcutaneously, while triptorelin is administered intramuscularly; each treatment can be given once every 24 to 26 weeks, as applicable.
Injection site reactions associated with injectable treatments may include burning and stinging. Although such reactions rarely lead to treatment discontinuation, they can cause discomfort and distress to patients. For some patients, the injections are also associated with pain and anxiety, which may affect treatment adherence. Various factors, such as formulation, methods of injection (SC vs. IM), and injection site (abdomen vs. buttock or thigh) may impact patients' subjective experience of injection site reactions. Therefore, this study was designed to compare patients' as well as health care providers' perceptions of injection site tolerability following the IM injection of triptorelin pamoate or SC injection of leuprolide.
One earlier study assessed attitudes of European patients with prostate cancer toward physicians and treatments, and included patients' assessments of GnRH agonist therapy, including clinical criteria, lifestyle or convenience issues, and frequency of injections (Schulman, 2007). However, to our knowledge, the present study is the first to assess the perceptions of patients and health care providers (i.e., those who administered the injections and questionnaires) regarding specific tolerability issues with different GnRH agonists.
The study protocol was approved by an institutional review board (Schulman Associates) and conducted in accordance with Good Clinical Practice (Food and Drug Administration [FDA], 1996) and all applicable codes and regulations, which included providing full study details to eligible patients, explaining all risks, and giving patients adequate time to consider the potential risks and benefits. Written informed consent was obtained from each patient by health care providers (i.e., registered nurse [RN], licensed practical nurse [LPN], advanced practice registered nurse [APRN], medical doctor [MD], or medical assistant [MA]) or study site coordinators before any study procedure was initiated.
Approximately 100 male patients were to be enrolled from 10 to 20 different clinical sites. These patients must have been aged 18 years or older with a diagnosis of advanced prostate cancer and must have been a candidate for treatment with triptorelin IM or leuprolide SC. Patients had to have a life expectancy of 1 year or more and had to be capable of completing study questionnaires without assistance. Excluded patients had a history of alcohol or drug abuse within the past year, required concomitant medications that could affect study assessments (e.g., topical medications used for pretreatment of injection site pain), had a known hypersensitivity to GnRH or luteinizing hormone-releasing hormone (LHRH) agonists, had a contraindication to treatment with triptorelin pamoate or leuprolide, or had significant medical problems that would affect the outcome of the study.
Study Design and Treatments
This multicenter, randomized, crossover, open-label study (NCT01161563) consisted of two study periods. During the first study period, patients were randomized 1:1 to receive a single injection of triptorelin pamoate 22.5 mg mixed with 2 mL sterile water administered intramuscularly in either buttock as specified in the prescribing information (Trelstar PI, 2013) or leuprolide acetate 45 mg mixed liquid in a prefilled delivery system administered subcutaneously in the upper- or mid-abdominal area. Block randomization was generated at the start of the study and used to ensure equal distribution among study centers. During study period 2, 24 to 26 weeks after the Period 1 clinic visits, patients crossed over and received the alternate treatment. Pretreatment of the injection site with topical anesthetic or analgesic agents was not permitted.
Questionnaires were administered to assess patient perceptions 10 to 15 minutes after each injection during both Study Periods. The primary assessment was patient bother from injection site burning and/or stinging, which was assessed on a Visual Analog Scale (VAS) from 0 (not bothered at all) to 10 (extremely bothered). VAS scales are the most commonly used scales to rate pain intensity and relief. They are easy to use, allow for a wide range of ratings, and provide reproducible results (Kelly, 2001; Macintyre, Scott, Schug, Visser, & Walker, 2010). Secondary assessments included patient bother from each of the following potential injection site effects: soreness, redness, bruising, itching, hardening, and swelling. These assessments were also collected 10 to 15 minutes post-injection and were reported on VAS from 0 to 10.
Other patient perceptions were assessed, including discomfort experienced (0 [no discomfort] to 10 [worst discomfort]), anxiety prior to receiving the injection (0 [not at all anxious] to 10 [extremely anxious]), anxiety about receiving another injection with the same product (0 [not at all anxious] to 10 [extremely anxious]), and overall satisfaction with injection experience (0 [completely satisfied] to 10 [not satisfied at all]).
Health care providers who prepared and administered the medications completed the questionnaire assessing their perceptions of treatment after each injection. Satisfaction with the following aspects of the medications was assessed on a VAS from 0 (strongly agree) to 10 (strongly disagree) (see Table 1). Other assessments by health care providers included distress the patient experienced associated with this injection (0 [no distress at all] to 10 [extremely distressed]) and overall satisfaction with injection experience (0 [completely satisfied] to 10 [not satisfied at all]).
Adverse events (AEs) were assessed for each study period for 24 hours after administration of study medication, and AEs were assessed at each study visit by asking patients questions regarding general health and hospitalization. An AE was defined as any undesirable medical event occurring to a patient, regardless of whether the event was related or unrelated to the study medication. Additionally, exacerbations of a pre-existing medical condition were considered an AE.
The study population included all patients who received injections of both study medications and answered the primary assessment question on the patient questionnaires following both study injections. Health care providers were defined as all study site clinicians who administered at least 1 injection and completed at least 1 clinician impression questionnaire. All patients who received at least one dose of study medication were included in safety analyses, which included treatment-emergent AEs, including serious AEs (i.e., those that limit daily activities and require intervention or therapy) and deaths.
It was estimated that a sample size of 81 patients per treatment group was necessary to provide 90% power to detect a difference between the groups. In a crossover study (Rohrig, du Prel, Wachtlin, Kwiecien, & Blettner, 2010; Wellek & Bletner, 2012), this means 81 patients had to complete both treatments (triptorelin pamoate/ leuprolide acetate). The target was a total of 100 patients enrolled to have at least 80 who would complete the study. All statistical comparisons for patient perceptions were conducted as two-sided tests, with p [less than or equal to] 0.05 considered statistically significant. Primary and secondary assessments were analyzed using an analysis of variance (ANOVA) model, adjusting for sequence, patient within sequence, period, and treatment. Clinician perception and safety data are summarized descriptively.
A total of 118 patients were randomized, with 63 randomized to receive triptorelin IM first and 55 to receive leuprolide SC first. Of the 107 patients who completed the study, 58 patients received triptorelin IM first, and 49 patients received leuprolide SC first. Demographic and physical characteristics of patients at baseline were generally similar between the two groups (see Table 2). Reasons for not completing the study included non-compliance with the study protocol, loss of follow up, and refusal or inability to participate further.
Patients reported significantly less post-injection burning and/or stinging with triptorelin IM than with leuprolide SC (p < 0.0001) (see Figure 1). In addition, significantly less post-injection soreness and less discomfort were reported with triptorelin IM than with leuprolide SC (both p < 0.0001) (see Figure 2). Results from other secondary assessments are reported in Table 3. Triptorelin IM versus leuprolide SC was associated with significantly less bother by redness, itching, and hardening (p [less than or equal to] 0.04), numerically less bother from bruising and swelling, and significantly greater satisfaction with overall injection experience (p = 0.0009). Significantly more anxiety prior to injection (p = 0.0271) and significantly more anxiety about a future injection with the same product (p = 0.0006) were reported with leuprolide SC than with triptorelin IM.
Clinicians reported less patient distress with triptorelin IM versus leuprolide SC (see Figure 3). Clinicians also reported greater overall satisfaction with triptorelin IM than leuprolide SC (see Figure 3). In addition, clinicians reported more ease of injection with triptorelin IM versus leuprolide SC and felt more protected from accidental needle sticks after administering triptorelin versus leuprolide (see Figure 4). Clinicians' satisfaction assessments with other aspects of the study medications are reported in Table 4, with greater satisfaction with individual aspects reported with triptorelin versus leuprolide.
Both medications used in this study were generally well tolerated. Injection site pain was the most commonly reported AE and was reported by one patient in the triptorelin IM group and two patients in the leuprolide SC group. Other AEs reported were cystitis (1 patient in the triptorelin group), diarrhea (1 patient in the leuprolide group), and urinary retention (1 patient in the triptorelin group). No serious AEs were reported during this study. No patients discontinued from the study as the result of an AE.
In the present study, patients reported that triptorelin IM is associated with significantly less post-injection burning and/or stinging than leuprolide SC. In addition, significantly less post-injection soreness, discomfort, bother by redness, itching, hardening of injection site, and anxiety were reported with triptorelin IM versus leuprolide SC. Similarly, patients reported significantly greater satisfaction with triptorelin IM versus leuprolide SC. Clinicians reported greater overall satisfaction and lower perceived patient distress with triptorelin IM versus leuprolide SC. Clinicians also reported greater convenience, ease, and satisfaction for all questionnaire parameters, including injection setup, preparation, administration, and disposal with triptorelin IM versus leuprolide SC. Both treatments were well tolerated.
The efficacy and tolerability of triptorelin pamoate IM and leuprolide acetate SC in patients with advanced prostate cancer have been previously established (Sanofi-Aventis US, LLC, 2011; Watson Pharma, Inc., 2013). An earlier parallel-group, randomized, controlled multicenter study compared the efficacy and tolerability of triptorelin pamoate with leuprolide acetate in 284 men with advanced cancer (Heyns, Simonin, Grosgurin, Schall, & Porchet, 2003). Notably, however, both medications in the study were administered intramuscularly (Heyns et al., 2003). Findings from the study showed that triptorelin and leuprolide were both effective in maintaining castration and had similar tolerability (Heyns et al., 2003). When there is comparable efficacy between treatment options, a patient's preference should be considered when making decisions about treatments (Wennberg, 2002).
Understanding individual patients' preferences for medications is important in clinical practice (Blinman, King, Norman, Viney, & Stockier, 2012). It allows physicians to tailor cancer treatments to individual patients (Blinman et al., 2012). Moreover, patient preferences for a medication can affect treatment compliance, and consequently, treatment outcomes (Cameron, 1996). Treatment tolerability, complexity and convenience of treatment regimen, and the duration of treatment also affect patient compliance with treatment (Anderson, 2003; Cameron, 1996). Additional studies to further assess perceptions of GnRH agonists and the effect of these perceptions on treatment compliance are warranted to identify medication factors that could potentially improve compliance.
Using VAS questionnaires, which are widely used during clinical trials, this study provided important information about patients' and clinicians' perceptions of two different GnRH agonist therapies. The VAS questionnaire is an easy and convenient tool that can be rapidly completed by patients or clinicians (Torrance, Feeny, & Furlong, 2001; Wewers & Lowe, 1990).
However, there are limitations to findings obtained with VAS assessments. One limitation is measurement bias; people tend to avoid choosing the extreme ends of a continuous scale (Blinman et al., 2012). Comparability of scores between respondents is also limited (Blinman et al., 2012) because the VAS is subjective in nature and based on personal perceptions (Wewers & Lowe, 1990). Moreover, some patients may not conceptually understand the VAS, which has been noted with elderly patients (Wewers & Lowe, 1990). An additional limitation of the study is that AEs were evaluated for only 24 hours after administration of study medication. Certain longer-term AEs would not have been captured in this study. A future study assessing AEs for at least 72 hours post-injection would further describe the tolerability of GnRH agonists.
Despite the study's limitations, the present findings provide important information regarding patients' perceptions of triptorelin IM versus leuprolide SC. The differences in perceptions between these medications may be attributable to the different routes of administration. In general, advantages of SC injections include a greater area for target injection sites, and injections can be more easily self-administered (Prettyman, 2005). In addition, the patient's muscle mass does not need to be considered, and SC injections generally have a better safety profile (Prettyman, 2005). On the other hand, IM injections allow for a greater volume of medication to be delivered, and medications that are irritating to SC tissues may be less so when administered intramuscularly (Prettyman, 2005).
Findings from the present study suggest that patients may prefer the IM GnRH agonist injection to the SC injection. Few studies of patients' preferences for IM or SC injections have been published. To our knowledge, perceptions of the tolerability of GnRH agonists have not been previously evaluated. However, results from a study conducted in patients with diabetes mellitus demonstrated that seven out of eight patients reported equal pain when injecting insulin IM versus SC (Vaag, Pedersen, Lauritzen, Hildebrandt, & Beck-Nielsen, 1990). Findings from a previous randomized, open-label, parallel-group study of 620 men with prostate cancer suggest that SC injections may be associated with more frequent injection-site reactions than IM injections (Klotz et al., 2008). In the study, 40% of patients given SC degarelix, a GnRH receptor antagonist, reported injection-site reactions, compared with less than 1% of patients given IM leuprolide (Klotz et al., 2008). Future studies are needed to better understand how the route of administration affects patients' and clinicians' preferences for medications.
Triptorelin IM and leuprolide SC were both well tolerated, but patients reported less post-injection burning and/or stinging, soreness, discomfort, and anxiety with triptorelin IM versus leuprolide SC. Similarly, clinicians reported greater overall satisfaction, convenience, ease, as well as greater patient satisfaction and lower perceived patient distress with triptorelin IM versus leuprolide SC. Although the present study had limitations, many inherent to the limitations of VAS questionnaires in general, it is the first study to provide important information regarding preference for GnRH agonists. Future studies are warranted to further determine factors that may contribute to and affect patient preferences and treatment compliance.
Treatment with androgen deprivation therapy, including gonadotropin releasing hormone (GnRH) agonists such as subcutaneous (SC) leuprolide acetate or intramuscular (IM) triptoreline pamoate, is used as palliative therapy in men with advanced prostate cancer. There are no known studies that have compared the tolerability of IM and SC injections in men with prostate cancer.
Objective or Purpose
This study was conducted to assess patients' and health care providers' ratings of injection site tolerability associated with leuprolide or triptorelin administration.
This was a crossover, open-label study that used a Visual Analog Scale to assess patient and health care provider ratings of tolerability 10 to 15 minutes following injection with leuprolide or triptorelin pamoate in 118 men with advanced prostate cancer. Adverse event data were also collected.
The study was completed by 107 patients (triptorelin, n = 58; leuprolide, n = 49). Although both treatments were well tolerated overall, triptorelin IM was associated with a more favorable tolerability profile that included less soreness, discomfort, redness, and itching: Both patients and clinicians alike reported greater satisfaction with triptorelin IM compared with leuprolide SC.
This is the first study of men with advanced prostate cancer to suggest that patients and clinicians have a preference for a particular GnRH treatment based on tolerability.
Level of Evidence--II (Polit & Beck, 2012)
Acknowledgements: The authors wish to thank Anny Wu, PharmD, Marsha Hall, BA, and Matthew Dougherty, BA (Scientific Connexions, Newtown, PA), for providing medical writing and editorial assistance, supported by Watson Pharma, Inc. All study sites received funding from Watson Pharma, Inc. to cover expenses of the investigators for conducting the study.
Note: Publication of this article is supported by a sponsorship provided by Watson Pharma. The manuscript has undergone peer review. The information does not necessarily reflect the opinions of SUNA or the sponsor.
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Neal D. Shore, MD, FACS, is Managing Partner, Atlantic Urology Clinics, and Director, CP/, the Carolina Urologic Research Center, Myrtle Beach, SC.
Paul Sieber, MD, FACS, is a Urologist, Lancaster Urology, Lancaster, PA.
Leanne Schimke, MSN, CRNP, FNP-C, CUNP, is a Nurse Practitioner, Lancaster Urology, Lancaster, PA.
Adam Perzin, MD, is Vice-President of Delaware Valley Urology, Mr. Laurel, NJ.
Scott Olsen, MPH, is Associate Director, Clinical Affairs, Watson Pharmaceuticals, Salt Lake City, UT.
Table 1. Components of Overall Satisfaction Rated by Health Care Providers * Time required to administer the product was reasonable. * Convenience of storage before administration. * Instructions simple and easy to understand. * All components of injection device were easy to identify. * Time required to setup for the injection was reasonable. * It was easy to prepare the device before injection. * The product was easy to mix using the device. * It was easy to draw the product into the syringe and attach to the needle. * Time required to prepare the product was reasonable. Table 2. Demographic and Physical Characteristics at Baseline (Per-Protocol Population) Triptorelin Leuprolide First First Overall Characteristic (n = 58) (n = 49) (N = 107) Age (years) Mean (SD) 73.2 (9.6) 75.0 (9.6) 74.0 (9.7) Range 57 to 91 56 to 91 56 to 91 Race, n (%) White 44.0 (76) 38.0 (78) 82.0 (77) African American 12.0 (21) 10.0 (20) 22.0 (21) Asian 1.0 (2) 0.0 1.0 (1) American Indian/ 1.0 (2) 0.0 1.0 (1) Alaska Native Native Hawaiian/ 0.0 1.0 (2) 1.0 (1) Pacific Islander Ethnicity, n (%) Hispanic or Latino 2.0 (3) 3.0 (6) 5.0 (5) Not Hispanic or Latino 56.0 (97) 46.0 (94) 102.0 (95) Previous GnRH Therapy, n (%) 38.0 (66) 31.0 (63) 69.0 (64) Leuprolide (IM) 9.0 (16) 9.0 (18) 18.0 (17) Leuprolide (SC) 22.0 (38) 18.0 (37) 40.0 (37) Triptorelin 7.0 (12) 4.0 (8) 11.0 (10) Height, cm Mean (SD) 176.9 (7.6) 174.8 (7.2) 175.9 (7.5) Weight, kg Mean (SD) 89.5 (17.6) 89.9 (22.8) 89.7 (20.0) Range 57.6 to 163 49.1 to 165 49.1 to 165 Notes: GnRH = gonadotropin-releasing hormone, IM = intramuscular, SC = subcutaneous. Table 3. Results From Secondary Assessments of Patient Perceptions Triptorelin Injection Characteristic (N = 107) Bother from redness Adjusted mean (95% CI) 3.39 (1.57 to 5.22) Range 0 to 28 Bother from bruising Adjusted mean (95% CI) 2.95 (1.12 to 4.77) Range 0 to 31 Bother from itching Adjusted mean (95% CI) 2.70 (1.49 to 3.91) Range 0 to 17 Bother from hardening Adjusted mean (95% CI) 3.47 (1.62 to 5.31) Range 0 to 34 Bother from swelling Adjusted mean (95% CI) 3.04 (1.41 to 4.68) Range 0 to 18 Anxiety prior to injection Adjusted mean (95% CI) 12.42 (7.38 to 17.46) Range 0 to 99 Anxiety post-injection * Adjusted mean (95% CI) 6.65 (2.11 to 11.19) Range 0 to 94 Dissatisfaction with overall injection experience Adjusted mean (95% CI) 5.21 (1.47 to 8.96) Range 0 to 91 Leuprolide Injection Characteristic (N = 107) Bother from redness Adjusted mean (95% CI) 6.26 (4.43 to 8.09) Range 0 to 87 Bother from bruising Adjusted mean (95% CI) 4.90 (3.08 to 6.73) Range 0 to 96 Bother from itching Adjusted mean (95% CI) 5.14 (3.93 to 6.34) Range 0 to 47 Bother from hardening Adjusted mean (95% CI) 6.16 (4.31 to 8.00) Range 0 to 99 Bother from swelling Adjusted mean (95% CI) 5.01 (3.37 to 6.64) Range 0 to 98 Anxiety prior to injection Adjusted mean (95% CI) 19.05 (14.00 to 24.09) Range 0 to 100 Anxiety post-injection * Adjusted mean (95% CI) 17.27(12.73 to 12.81) Range 0 to 100 Dissatisfaction with overall injection experience Adjusted mean (95% CI) 13.44 (9.70 to 17.19) Range 0 to 100 Characteristic Difference Bother from redness Adjusted mean (95% CI) 2.87 (0.28 to 5.45) Range p = 0.0302 Bother from bruising Adjusted mean (95% CI) 1.96 (-0.61 to 4.52) Range p=0.1331 Bother from itching Adjusted mean (95% CI) 2.43 (0.74 to 4.13) Range p = 0.0052 Bother from hardening Adjusted mean (95% CI) 2.69 (12.60 to 23.46) Range p = 0.0386 Bother from swelling Adjusted mean (95% CI) 1.96 (-0.29 to 4.21) Range p = 0.0869 Anxiety prior to injection Adjusted mean (95% CI) 6.62 (0.76 to 12.48) Range p = 0.0271 Anxiety post-injection * Adjusted mean (95% CI) 10.62 (4.68 to 16.56) Range p = 0.0006 Dissatisfaction with overall injection experience Adjusted mean (95% CI) 8.23 (3.47 to 12.99) Range p = 0.0009 * Anxiety post-injection about getting another injection with the same product. Table 4. Clinicians' Satisfaction With Various Aspects of the Study Medications Triptorelin Leuprolide Characteristic Injection Injection Time required to administer the product was reasonable Mean (SD) 5.32 (12.47) 15.56 (17.67) Range 0 to 98 0 to 60 Convenience of storage before administration Mean (SD) 3.59 (9.61) 10.72 (15.6) Range 0 to 83 0 to 88 Instructions simple and easy to understand Mean (SD) 5.04 (10.53) 9.73 (13.24) Range 0 to 76 0 to 77 All components of injection device were easy to identify Mean (SD) 4.27 (9.48) 11.17 (16.9) Range 0 to 79 0 to 97 Time required to setup for the injection was reasonable Mean (SD) 4.41 (8.92) 12.47 (16.94) Range 0 to 71 0 to 94 It was easy to prepare the device before injection Mean (SD) 5.29 (10.18) 13.16 (16.72) Range 0 to 78 0 to 94 The product was easy to mix using the device Mean (SD) 6.21 (12.46) 15.45 (17.99) Range 0 to 80 0 to 93 It was easy to draw the product into the syringe and attach to the needle Mean (SD) 7.54 (13.83) 19.0 (20.28) Range 0 to 78 0 to 81 Time required to prepare the product was reasonable Mean (SD) 4.88 (9.16) 16.88 (19.36) Range 0 to 75 0 to 86
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|Author:||Shore, Neal D.; Sieber, Paul; Schimke, Leanne; Perzin, Adam; Olsen, Scott|
|Date:||Sep 1, 2013|
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