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Foreword According to the China Cancer Registration Report, the incidence of prostate cancer in China ranks sixth among male malignant tumors, and the mortality rate ranks tenth among male malignant tumors [1]
.
Radical prostatectomy (RP) is usually the first choice for patients diagnosed with early-stage prostate cancer.
However, after radical surgery, some patients may experience increased prostate-specific antigen (PSA) again, and then progress to high-risk PSA recurrent prostate.
cancer
.
For these patients, salvage external radiation therapy (RT) is usually performed clinically, but the prognosis and survival rate of the patients are mediocre
.
So, can the new endocrine drugs that have made great strides in the clinical treatment of castration-resistant prostate cancer (CRPC) in recent years bring survival benefits to these patients? A study published in the journal Eur Urol Oncol [2] examined the safety and efficacy of enzalutamide in combination with salvage RT and ADT
.
1 Study description This study is a three-center, prospective, single-arm, phase II clinical trial involving prostate cancer patients with Gleason score 7-10 who had previously received RP in the range of 0.
2 - 4.
0 ng/dl, and 4 postoperatively.
PSA recurrence occurred within the year, no prior hormonal therapy, and no imaging evidence of metastasis
.
Thirty-eight patients from April 2014 to February 2016 received 6 months of oral ADT plus 160 mg/day enzalutamide, concurrently with radiotherapy
.
Patients received enzalutamide + ADT (primarily a gonadotropin-releasing hormone agonist) for 2 months prior to treatment, followed by standard external beam RT at 64.
8-68 Gy for 6-8 weeks, and concurrently for 4 months of enzalutamide + ADT treatment
.
Among them, enzalutamide + ADT treatment should be completed within 2 months after salvage RT
.
The primary endpoint of the study was 2-year progression-free survival (PFS)
.
Secondary endpoints included 3-year PFS, safety, and patient-reported quality of life (QOL)
.
Patients in this study were monitored for PSA at the start of the trial, at week 8, week 26, and every 3 months thereafter
.
Figure 1 Study Design 2 Study Results Of the 38 patients recruited for safety, a total of 37 patients completed treatment and can be assessed for testosterone recovery after 2 years
.
Preliminary findings suggest that enzalutamide has a favorable safety profile in high-risk prostate cancer patients
.
A total of 11 patients (29%) reported grade 3 adverse events in the study, the most common being grade 3 hypertension, headache, tremor, back pain, and fatigue
.
However, none of these adverse events were confirmed to be related to enzalutamide
.
The median follow-up time for efficacy was 37.
5 months (95% CI: 26.
2, 41.
7), and the 2-year PFS rate in the enzalutamide group was 65% (95% CI: 47, 78), compared with 51% (95% CI: 47, 78) before.
: 33, 67) were significantly higher than the historical control rate (as shown in Figure 2)
.
Figure 2 Estimated progression-free survival of patients in the study The 3-year PFS rate in the enzalutamide group was 54% (95% CI: 37,68)
.
Patients with positive lymph nodes at surgery (n=8) had a poor prognosis, with a 2-year PFS rate of only 25% (95% CI: 3.
7, 55.
8)
.
Compared with the overall study population, node-negative patients had improved PFS, with a 2-year PFS rate of 76% (95% CI: 54, 88) and a 3-year PFS rate of 64% (95% CI: 42, 79), As shown in Table 1
.
Table 1 Incidence of PFS at 12, 24, and 36 months in all patients and in node-negative (N0) and resected node-positive (N1) subgroups Thus, enzalutamide significantly prolongs 2-year survival in high-risk prostate cancer patients and 3 years PFS
.
Quality of life In addition, all patients were asked to complete the EPIC short form before the start of the trial, at 12 weeks after the start of the trial, and at 12, 24, and 36 months after the end of treatment [3] to assess patients' quality of life outcomes
.
On a scale out of 100, with 100 being perfect and 0 being no function, the mean baseline scores for urinary irritation, incontinence, bowel function, sexual function, and hormonal symptoms in this study were 88.
5, 56, 97, 19 and 93
.
This suggests that these patients had a higher degree of urinary incontinence and a very high degree of sexual dysfunction after radical prostatectomy, before any additional treatment, compared with the normal population
.
However, patients usually do not have urinary irritation, intestinal symptoms, and hormonal symptoms
.
Post-treatment results are shown in Table 2 and Figure 3.
The patient's urinary irritation and bowel symptoms worsened at 3 months, consistent with RT, and improved at 12 months
.
Urinary incontinence remained generally stable throughout the study
.
Sexual function was worst at 3 months, but improved above baseline at 36 months
.
Table 2 Summary of clinical symptom decline for each EPIC domain at 3, 12, 24 and 36 months Figure 3 Spider plot of EPIC scales over time including (A) urinary irritation, (B) urinary incontinence, ( C) intestinal symptoms, (D) sexual function and (E) hormonal symptoms
.
The red line represents the estimated median value for assessable survey results over time
.
Higher scores reflect better functional improvements on a scale of 0-100
.
3 Summary This study confirms that salvage enzalutamide and ADT combined with radiotherapy is safe 6 months after prostatectomy in patients with high-risk PSA recurrence, and the results are also shown on 2- and 3-year PFS.
Encouraging curative effect
.
Therefore, in addition to salvage radiotherapy alone, the combination of enzalutamide and ADT may become a new treatment direction for prostate cancer patients with high risk of PSA recurrence in the future
.
We also expect Enzalutamide to show more of its own on the big stage of prostate cancer treatment
.
References: [1] National Cancer Center, Bureau of Disease Control and Prevention, Health and Family Planning Commission.
2014 China Cancer Registry Work Report.
[2] Bitting RL, Healy P, George DJ, et al.
Phase II Trial of Enzalutamide and Androgen Deprivation Therapy with Salvage Radiation in Men with High-risk Prostate-specific Antigen Recurrent Prostate Cancer: The STREAM Trial.
Eur Urol Oncol.
2021 Dec;4(6):948-954.
[3] Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG.
Development and validation of the Expanded Prostate Cancer Index Composite (EPIC) for comprehensive assessment of health-relat- ed quality of life in men with prostate cancer.
Urology 2000;56:899–905.
.
Radical prostatectomy (RP) is usually the first choice for patients diagnosed with early-stage prostate cancer.
However, after radical surgery, some patients may experience increased prostate-specific antigen (PSA) again, and then progress to high-risk PSA recurrent prostate.
cancer
.
For these patients, salvage external radiation therapy (RT) is usually performed clinically, but the prognosis and survival rate of the patients are mediocre
.
So, can the new endocrine drugs that have made great strides in the clinical treatment of castration-resistant prostate cancer (CRPC) in recent years bring survival benefits to these patients? A study published in the journal Eur Urol Oncol [2] examined the safety and efficacy of enzalutamide in combination with salvage RT and ADT
.
1 Study description This study is a three-center, prospective, single-arm, phase II clinical trial involving prostate cancer patients with Gleason score 7-10 who had previously received RP in the range of 0.
2 - 4.
0 ng/dl, and 4 postoperatively.
PSA recurrence occurred within the year, no prior hormonal therapy, and no imaging evidence of metastasis
.
Thirty-eight patients from April 2014 to February 2016 received 6 months of oral ADT plus 160 mg/day enzalutamide, concurrently with radiotherapy
.
Patients received enzalutamide + ADT (primarily a gonadotropin-releasing hormone agonist) for 2 months prior to treatment, followed by standard external beam RT at 64.
8-68 Gy for 6-8 weeks, and concurrently for 4 months of enzalutamide + ADT treatment
.
Among them, enzalutamide + ADT treatment should be completed within 2 months after salvage RT
.
The primary endpoint of the study was 2-year progression-free survival (PFS)
.
Secondary endpoints included 3-year PFS, safety, and patient-reported quality of life (QOL)
.
Patients in this study were monitored for PSA at the start of the trial, at week 8, week 26, and every 3 months thereafter
.
Figure 1 Study Design 2 Study Results Of the 38 patients recruited for safety, a total of 37 patients completed treatment and can be assessed for testosterone recovery after 2 years
.
Preliminary findings suggest that enzalutamide has a favorable safety profile in high-risk prostate cancer patients
.
A total of 11 patients (29%) reported grade 3 adverse events in the study, the most common being grade 3 hypertension, headache, tremor, back pain, and fatigue
.
However, none of these adverse events were confirmed to be related to enzalutamide
.
The median follow-up time for efficacy was 37.
5 months (95% CI: 26.
2, 41.
7), and the 2-year PFS rate in the enzalutamide group was 65% (95% CI: 47, 78), compared with 51% (95% CI: 47, 78) before.
: 33, 67) were significantly higher than the historical control rate (as shown in Figure 2)
.
Figure 2 Estimated progression-free survival of patients in the study The 3-year PFS rate in the enzalutamide group was 54% (95% CI: 37,68)
.
Patients with positive lymph nodes at surgery (n=8) had a poor prognosis, with a 2-year PFS rate of only 25% (95% CI: 3.
7, 55.
8)
.
Compared with the overall study population, node-negative patients had improved PFS, with a 2-year PFS rate of 76% (95% CI: 54, 88) and a 3-year PFS rate of 64% (95% CI: 42, 79), As shown in Table 1
.
Table 1 Incidence of PFS at 12, 24, and 36 months in all patients and in node-negative (N0) and resected node-positive (N1) subgroups Thus, enzalutamide significantly prolongs 2-year survival in high-risk prostate cancer patients and 3 years PFS
.
Quality of life In addition, all patients were asked to complete the EPIC short form before the start of the trial, at 12 weeks after the start of the trial, and at 12, 24, and 36 months after the end of treatment [3] to assess patients' quality of life outcomes
.
On a scale out of 100, with 100 being perfect and 0 being no function, the mean baseline scores for urinary irritation, incontinence, bowel function, sexual function, and hormonal symptoms in this study were 88.
5, 56, 97, 19 and 93
.
This suggests that these patients had a higher degree of urinary incontinence and a very high degree of sexual dysfunction after radical prostatectomy, before any additional treatment, compared with the normal population
.
However, patients usually do not have urinary irritation, intestinal symptoms, and hormonal symptoms
.
Post-treatment results are shown in Table 2 and Figure 3.
The patient's urinary irritation and bowel symptoms worsened at 3 months, consistent with RT, and improved at 12 months
.
Urinary incontinence remained generally stable throughout the study
.
Sexual function was worst at 3 months, but improved above baseline at 36 months
.
Table 2 Summary of clinical symptom decline for each EPIC domain at 3, 12, 24 and 36 months Figure 3 Spider plot of EPIC scales over time including (A) urinary irritation, (B) urinary incontinence, ( C) intestinal symptoms, (D) sexual function and (E) hormonal symptoms
.
The red line represents the estimated median value for assessable survey results over time
.
Higher scores reflect better functional improvements on a scale of 0-100
.
3 Summary This study confirms that salvage enzalutamide and ADT combined with radiotherapy is safe 6 months after prostatectomy in patients with high-risk PSA recurrence, and the results are also shown on 2- and 3-year PFS.
Encouraging curative effect
.
Therefore, in addition to salvage radiotherapy alone, the combination of enzalutamide and ADT may become a new treatment direction for prostate cancer patients with high risk of PSA recurrence in the future
.
We also expect Enzalutamide to show more of its own on the big stage of prostate cancer treatment
.
References: [1] National Cancer Center, Bureau of Disease Control and Prevention, Health and Family Planning Commission.
2014 China Cancer Registry Work Report.
[2] Bitting RL, Healy P, George DJ, et al.
Phase II Trial of Enzalutamide and Androgen Deprivation Therapy with Salvage Radiation in Men with High-risk Prostate-specific Antigen Recurrent Prostate Cancer: The STREAM Trial.
Eur Urol Oncol.
2021 Dec;4(6):948-954.
[3] Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG.
Development and validation of the Expanded Prostate Cancer Index Composite (EPIC) for comprehensive assessment of health-relat- ed quality of life in men with prostate cancer.
Urology 2000;56:899–905.
