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The prognostic value of nadir PSA level and time to nadir in high risk mHNPC patients
abstracts
Annals of Oncology
P1 114
Urinary spermine level as novel additional diagnostic marker of prostate cancer
Veronika V Bentrad1, Sergii V Gogol1, Sophia P Zaletok1, Yurii V Vitruk2, Eduard O Stakhovskyi2, Boghdan O Grechko2 1 Department of Tumor Biochemistry and Oncopharmacology, R.E. Kavetsky Institute of Experimental Pathology, Oncology and Radiobiology, Ukraine, 2Department of Plastic and Reconstructive Oncological Urology, National Cancer Institute Background: prostate cancer (PC) is one of the most common male cancer in the world, and it is one of the leading causes of mortality and momentous public health impact in many developed countries. Nowadays, PSA (prostate-specific antigen) test is used as a famous serum test for screening of prostate cancer. However, PSA test is nt sensitive and specific enough, because its high levels do not always indicate the presence of a malignant process in the prostate, and low - about its absence. Some studies suggest to use concentration of spermine in the urine as a novel noninvasive marker for PC diagnostics. Methods: Male patients age 51-79 with prostate cancer (I-IV stage) were enrolled. Diagnoses of all patients were established at the National Cancer Institute (Kyiv, Ukraine). Spermine concentration was determined in the morning urine samples of 38 patients with malignant tumors (I stage - 16%, II - 45%, III - 24%, IV - 15%) before treatment, 12 patients with prostate hyperplasia and 12 healthy men by ELISA kit. Results: It was found that concentration of spermine in the urine in patients with prostate cancer was lower by 7-34 times in comparison with healthy men and lower by 5-13 times than in patients with prostate hyperplasia. The same results were obtained previously in peripheral blood of PC patients by the high pressure liquid chromatography (HPLC). Conclusion: concentration of spermine in the urine shows potential to serve as a novel PC diagnostic non-invasive marker, which in turn can help to address the limited sensitivity and specificity problem of serum PSA test.
P1 116
The prognostic value of nadir PSA level and time to nadir in high risk mHNPC patients
Akihiro Asai, Itsuho Shirosima, Yushi Imasato, Masataka Furukawa Sasebo City General Hospital Background: The prognosis of patients with high risk metastatic hormone-naive prostate cancer is poor.The present study investigated the prognostic significance in Japanese men with high-risk mHNPC when stratified by the criteria in the LATITUDE trial, and initial experience with upfront abiraterone in high-risk mHNPC Methods: The present study retrospectively enrolled 60 men who were considered to be High risk mHNPC, at our institution from 2010 to 2018. Results: The median OS was 40 months (95% CI 33.1-49.2 months).The median time to CRPC was 34 months (95% CI 28.7-57.5 months ) in the low-risk mHNPC group and 15 months (95% CI 14.0-25.4 months, P ¼ 0.019) in the high-risk mHNPC group.In the high-risk mHNPC, the median time to CRPC was 36 months (95% CI 5.4-66.5 months ) in the low-PSA nadir group ( PSA nadir was less than 0.2 ng/ml) and 12 months (95% CI 6.8-17.1 months, P ¼ 0.005) in the high-PSA nadir group ( PSA nadir was more than 0.2 ng/ml).The median time to CRPC was 15 months (95% CI 10.8-19.1 months ) in the low-iPSA group ( iPSA was less than 330 ng/ml) and 15 months (95% CI 4.7-25.2 months, P ¼ 0.83) in the high-iPSA group ( PSA nadir was more than 330 ng/ml).Time to nadir is positively associated with time to nadir (P > 0.001 ).Multivariate analysis revealed that longer time to nadir was significant prognostic factor. Conclusion: Prognosis of high-risk mHNPC was poor in Japanese population.It revealed that PSA response play an important role in progression of high-risk mHNPC.
P1 120
Gemcitabine/Cisplatin therapy for an urothelial carcinoma patient undergoing hemodialysis: a case report
Yumiko Goto1, Kent Kanao2, Masafumi Onishi1, Kogenta Nakamura2 Department of Hospital Pharmacy of Aichi Medical University, 2Urology of Aichi Medical University
1
Background: Gemcitabine/Cisplatin (GC) therapy is first-line chemotherapy for advanced urothelial carcinoma (UC). The Renal Impairment Clinical Practice Guidelines 2016 suggest that, Cisplatin (CDDP) may be administered by up to 50% of
Volume 30 | Supplement 6 | October 2019
standard dose for patients with hemodialysis (HD) because of the renal toxicity. The evidence is, however, scanty to evaluate safety. We report a case of GC therapy for a UC patient undergoing HD. Patient: A 80-years old male with bilateral papillary UC had a total renal ureteral resection and underwent HD. Two courses of adjuvant GC therapy were to be performed. The standard dose of Gemcitabine (GEM) and 50% of standard dose of CDDP were administered on the same day based on CDDP and GEM interview form and literature for HD patients. HD started 6 hours after GEM administration and 1 hour after CDDP administration. The volume of infusion was 600 mL; diuretics were not used. Side effects were evaluated according to Common Terminology Criteria for Adverse Events v4.0. Results: In first course, Grade 4 side effects were observed: leukopenia, neutropenia and thrombocytopenia. They were treated by granulocyte-colony stimulating factor (G-CSF) administration and platelet transfusion. No febrile neutropenia was observed. Because the second course was administered without reducing the doses, G-CSF was prophylactically administered, and the Grade 4 side effects were reduced to Grade 3. No relapse was observed by now. Conclusion: We could performed GC therapy safety for a patient with advanced UC undergoing HD by managing adverse event adequately.
P1 125
3 cases of undifferentiated embryonal sarcoma of the liver (UESL) in adult
Motoko Arakaki1, Kazuki Sudo1, Yuki Kojima1, Yohei Ohtake1, Takuji Seo1, Hitomi Okuma1, Emi Noguchi1, Maki Tanioka1, Akihiko Shimomura1, Kan Yonemori1, Akihiko Yoshida2, Yasuhiro Fujiwara1, Kenji Tamura1 1 Department of Breast and Medical Oncology, Natinal Cancer Center Hospital, 2 Department of Pathology, Natinal Cancer Center Hospital Background: UESL is a malignant mesenchymal tumor mainly occurring in children between the ages of 5-10 years, and rare in adult. There is no established treatment for UESL, so it is treated with agent commonly used for pediatric sarcoma. Here, we report 3 cases of UESL in our department from 2008 to 2018. Case 1: The patient was a 30-year-old female. She noticed upper abdominal pain, and a tumor was found in the left upper abdomen. She underwent complete resection and did not receive adjuvant chemotherapy (AC). 9 months later, she had a first recurrence. She received ifosfamide (IFM) monotherapy followed tumor resection. However, she had recurrence again and was subsequently treated with monotherapy of eribulin, trabectedin, and dacarbazine, she died of drug-induced lung injury due to dacarbazine after 3 years and 9 months from diagnosis. Case 2: The patient was a 18-year-old female. She had a epigastric pain and intra-hepatic hemorrhage due to liver tumor was found. The tumor was completely resected at elective surgery following emergency hemostatic therapy. 3 months later, she had recurrence and received doxorubicin (DXR) þ IFM therapy followed residual tumor resection. She is alive without recurrence over 2 years after surgery. Case 3: The patient was a 20-year-old female. She noticed epigastric pain and she was treated as a liver abscess. Next month, perforation of the right hepatic lobular mass was found. She had trisegmentectomy, but complete resection was difficult due to infiltration to other organs. We considered that the remaining lesion will increase in high probability, we have started VDC (Vincristine, DXR, Cyclophosphamide) therapy and now on going. Conclusion: Two cases who did not received AC had recurrence in a short period after surgery despite complete resection, and one is currently continuing AC. These show that USEL in adult is at high risk of recurrence. Further study is needed to develop therapy for embryonal sarcoma especially in adult.
P1 126
The clinical efficacy of eribulin to soft tissue sarcoma patients: differences in histological subtypes
Kenji Nakano1, Yuki Funauchi2, Keiko Hayakawa2, Taisuke Tanizawa2, Keisuke Ae2, Seiichi Matsumoto2, Shunji Takahashi1 1 Department of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, 2Department of Orthopedic Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research Background: In Japan, eribulin can be indicated to all histology of STS and available as 2nd or later line chemotherapy; however, the clinical evidence of eribulin to STS based on the international randomized clinical trial is limited to L-sarcoma (leiomyosarcoma and liposaroma) as 3rd or later line chemotherapy yet. Methods: We retrospectively reviewed STS patients treated with eribulin between March 2016 and December 2018 in our institute. Prognoses of all patients, differences of prognoses by histology (comparison of L-sarcoma and other histology) and differences of prognoses by treatment line (comparison of 2nd line and later line) in L-sarcoma were evaluated. Results: Total of 41 patients were enrolled in the analysis; 26 of them were L-sarcoma and 15 were other histology. In 26 L-sarcoma patients, 12 patients was leiomyosarcoma and the other 14 was liposarcoma. Among L-sarcoma patients, the media PFS was longer in liposarcoma (8.42 months, 95% CI: 5.67-11.17) than leiomyosarcoma (2.3 months, 95% CI: 1.35-3.32) significantly (p ¼ 0.021), but there were not differences in
doi:10.1093/annonc/mdz343 | vi123
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_6/mdz343.024/5583145 by Stockholm University Library user on 14 October 2019
more than MR4.5 over 2 years are necessary conditions for planning pregnancy. But 2 and more years could be said too long for young women who hope for children. In this case, we switched TKIs for achieving DMR as early as possible. But unexpected pregnancy occurred in MMR. As a result, she gave a birth without any major event under IFN-alpha therapy. Conclusion: The IFN-alpha therapy for pregnant female achieved safe and normal delivery.
Annals of Oncology
P1 114
Urinary spermine level as novel additional diagnostic marker of prostate cancer
Veronika V Bentrad1, Sergii V Gogol1, Sophia P Zaletok1, Yurii V Vitruk2, Eduard O Stakhovskyi2, Boghdan O Grechko2 1 Department of Tumor Biochemistry and Oncopharmacology, R.E. Kavetsky Institute of Experimental Pathology, Oncology and Radiobiology, Ukraine, 2Department of Plastic and Reconstructive Oncological Urology, National Cancer Institute Background: prostate cancer (PC) is one of the most common male cancer in the world, and it is one of the leading causes of mortality and momentous public health impact in many developed countries. Nowadays, PSA (prostate-specific antigen) test is used as a famous serum test for screening of prostate cancer. However, PSA test is nt sensitive and specific enough, because its high levels do not always indicate the presence of a malignant process in the prostate, and low - about its absence. Some studies suggest to use concentration of spermine in the urine as a novel noninvasive marker for PC diagnostics. Methods: Male patients age 51-79 with prostate cancer (I-IV stage) were enrolled. Diagnoses of all patients were established at the National Cancer Institute (Kyiv, Ukraine). Spermine concentration was determined in the morning urine samples of 38 patients with malignant tumors (I stage - 16%, II - 45%, III - 24%, IV - 15%) before treatment, 12 patients with prostate hyperplasia and 12 healthy men by ELISA kit. Results: It was found that concentration of spermine in the urine in patients with prostate cancer was lower by 7-34 times in comparison with healthy men and lower by 5-13 times than in patients with prostate hyperplasia. The same results were obtained previously in peripheral blood of PC patients by the high pressure liquid chromatography (HPLC). Conclusion: concentration of spermine in the urine shows potential to serve as a novel PC diagnostic non-invasive marker, which in turn can help to address the limited sensitivity and specificity problem of serum PSA test.
P1 116
The prognostic value of nadir PSA level and time to nadir in high risk mHNPC patients
Akihiro Asai, Itsuho Shirosima, Yushi Imasato, Masataka Furukawa Sasebo City General Hospital Background: The prognosis of patients with high risk metastatic hormone-naive prostate cancer is poor.The present study investigated the prognostic significance in Japanese men with high-risk mHNPC when stratified by the criteria in the LATITUDE trial, and initial experience with upfront abiraterone in high-risk mHNPC Methods: The present study retrospectively enrolled 60 men who were considered to be High risk mHNPC, at our institution from 2010 to 2018. Results: The median OS was 40 months (95% CI 33.1-49.2 months).The median time to CRPC was 34 months (95% CI 28.7-57.5 months ) in the low-risk mHNPC group and 15 months (95% CI 14.0-25.4 months, P ¼ 0.019) in the high-risk mHNPC group.In the high-risk mHNPC, the median time to CRPC was 36 months (95% CI 5.4-66.5 months ) in the low-PSA nadir group ( PSA nadir was less than 0.2 ng/ml) and 12 months (95% CI 6.8-17.1 months, P ¼ 0.005) in the high-PSA nadir group ( PSA nadir was more than 0.2 ng/ml).The median time to CRPC was 15 months (95% CI 10.8-19.1 months ) in the low-iPSA group ( iPSA was less than 330 ng/ml) and 15 months (95% CI 4.7-25.2 months, P ¼ 0.83) in the high-iPSA group ( PSA nadir was more than 330 ng/ml).Time to nadir is positively associated with time to nadir (P > 0.001 ).Multivariate analysis revealed that longer time to nadir was significant prognostic factor. Conclusion: Prognosis of high-risk mHNPC was poor in Japanese population.It revealed that PSA response play an important role in progression of high-risk mHNPC.
P1 120
Gemcitabine/Cisplatin therapy for an urothelial carcinoma patient undergoing hemodialysis: a case report
Yumiko Goto1, Kent Kanao2, Masafumi Onishi1, Kogenta Nakamura2 Department of Hospital Pharmacy of Aichi Medical University, 2Urology of Aichi Medical University
1
Background: Gemcitabine/Cisplatin (GC) therapy is first-line chemotherapy for advanced urothelial carcinoma (UC). The Renal Impairment Clinical Practice Guidelines 2016 suggest that, Cisplatin (CDDP) may be administered by up to 50% of
Volume 30 | Supplement 6 | October 2019
standard dose for patients with hemodialysis (HD) because of the renal toxicity. The evidence is, however, scanty to evaluate safety. We report a case of GC therapy for a UC patient undergoing HD. Patient: A 80-years old male with bilateral papillary UC had a total renal ureteral resection and underwent HD. Two courses of adjuvant GC therapy were to be performed. The standard dose of Gemcitabine (GEM) and 50% of standard dose of CDDP were administered on the same day based on CDDP and GEM interview form and literature for HD patients. HD started 6 hours after GEM administration and 1 hour after CDDP administration. The volume of infusion was 600 mL; diuretics were not used. Side effects were evaluated according to Common Terminology Criteria for Adverse Events v4.0. Results: In first course, Grade 4 side effects were observed: leukopenia, neutropenia and thrombocytopenia. They were treated by granulocyte-colony stimulating factor (G-CSF) administration and platelet transfusion. No febrile neutropenia was observed. Because the second course was administered without reducing the doses, G-CSF was prophylactically administered, and the Grade 4 side effects were reduced to Grade 3. No relapse was observed by now. Conclusion: We could performed GC therapy safety for a patient with advanced UC undergoing HD by managing adverse event adequately.
P1 125
3 cases of undifferentiated embryonal sarcoma of the liver (UESL) in adult
Motoko Arakaki1, Kazuki Sudo1, Yuki Kojima1, Yohei Ohtake1, Takuji Seo1, Hitomi Okuma1, Emi Noguchi1, Maki Tanioka1, Akihiko Shimomura1, Kan Yonemori1, Akihiko Yoshida2, Yasuhiro Fujiwara1, Kenji Tamura1 1 Department of Breast and Medical Oncology, Natinal Cancer Center Hospital, 2 Department of Pathology, Natinal Cancer Center Hospital Background: UESL is a malignant mesenchymal tumor mainly occurring in children between the ages of 5-10 years, and rare in adult. There is no established treatment for UESL, so it is treated with agent commonly used for pediatric sarcoma. Here, we report 3 cases of UESL in our department from 2008 to 2018. Case 1: The patient was a 30-year-old female. She noticed upper abdominal pain, and a tumor was found in the left upper abdomen. She underwent complete resection and did not receive adjuvant chemotherapy (AC). 9 months later, she had a first recurrence. She received ifosfamide (IFM) monotherapy followed tumor resection. However, she had recurrence again and was subsequently treated with monotherapy of eribulin, trabectedin, and dacarbazine, she died of drug-induced lung injury due to dacarbazine after 3 years and 9 months from diagnosis. Case 2: The patient was a 18-year-old female. She had a epigastric pain and intra-hepatic hemorrhage due to liver tumor was found. The tumor was completely resected at elective surgery following emergency hemostatic therapy. 3 months later, she had recurrence and received doxorubicin (DXR) þ IFM therapy followed residual tumor resection. She is alive without recurrence over 2 years after surgery. Case 3: The patient was a 20-year-old female. She noticed epigastric pain and she was treated as a liver abscess. Next month, perforation of the right hepatic lobular mass was found. She had trisegmentectomy, but complete resection was difficult due to infiltration to other organs. We considered that the remaining lesion will increase in high probability, we have started VDC (Vincristine, DXR, Cyclophosphamide) therapy and now on going. Conclusion: Two cases who did not received AC had recurrence in a short period after surgery despite complete resection, and one is currently continuing AC. These show that USEL in adult is at high risk of recurrence. Further study is needed to develop therapy for embryonal sarcoma especially in adult.
P1 126
The clinical efficacy of eribulin to soft tissue sarcoma patients: differences in histological subtypes
Kenji Nakano1, Yuki Funauchi2, Keiko Hayakawa2, Taisuke Tanizawa2, Keisuke Ae2, Seiichi Matsumoto2, Shunji Takahashi1 1 Department of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, 2Department of Orthopedic Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research Background: In Japan, eribulin can be indicated to all histology of STS and available as 2nd or later line chemotherapy; however, the clinical evidence of eribulin to STS based on the international randomized clinical trial is limited to L-sarcoma (leiomyosarcoma and liposaroma) as 3rd or later line chemotherapy yet. Methods: We retrospectively reviewed STS patients treated with eribulin between March 2016 and December 2018 in our institute. Prognoses of all patients, differences of prognoses by histology (comparison of L-sarcoma and other histology) and differences of prognoses by treatment line (comparison of 2nd line and later line) in L-sarcoma were evaluated. Results: Total of 41 patients were enrolled in the analysis; 26 of them were L-sarcoma and 15 were other histology. In 26 L-sarcoma patients, 12 patients was leiomyosarcoma and the other 14 was liposarcoma. Among L-sarcoma patients, the media PFS was longer in liposarcoma (8.42 months, 95% CI: 5.67-11.17) than leiomyosarcoma (2.3 months, 95% CI: 1.35-3.32) significantly (p ¼ 0.021), but there were not differences in
doi:10.1093/annonc/mdz343 | vi123
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_6/mdz343.024/5583145 by Stockholm University Library user on 14 October 2019
more than MR4.5 over 2 years are necessary conditions for planning pregnancy. But 2 and more years could be said too long for young women who hope for children. In this case, we switched TKIs for achieving DMR as early as possible. But unexpected pregnancy occurred in MMR. As a result, she gave a birth without any major event under IFN-alpha therapy. Conclusion: The IFN-alpha therapy for pregnant female achieved safe and normal delivery.