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Article ; Online: Late Recurrence of Metastatic Meningioma in the Lung in a Patient with Endometrial Cancer: A Case Report.

Alshibany, Aisha Mohammed / Al-Husaini, Hamed Homoud

2021 Volume 22, Page(s) e930708

Abstract: BACKGROUND Meningiomas are the most frequently diagnosed of all primary brain tumors, including glioblastomas, and of all other central nervous system tumors. While non-malignant meningiomas account for 36.7% of all primary brain tumors, malignant ... ...

Abstract	BACKGROUND Meningiomas are the most frequently diagnosed of all primary brain tumors, including glioblastomas, and of all other central nervous system tumors. While non-malignant meningiomas account for 36.7% of all primary brain tumors, malignant meningioma is much less common, accounting for just 0.6%. The annual incidence of meningiomas in the United States is 5.3 per 100 000 people. The median age of diagnosis is 64, and incidence rises steadily with advancing age. Furthermore, extracranial metastatic meningioma remains extremely rare (0.1%), with the most common location for metastasis being the lung. CASE REPORT We report a case of a patient with biopsy-proven endometrial adenocarcinoma with suspicious lung nodule, Stage IVB. She was managed with chemotherapy followed by surgery and radiation. During her course of management, she was found to have progressive pulmonary nodules. Later, biopsy from the pulmonary nodules showed a metastatic meningioma. CONCLUSIONS Our case highlights the importance of early recognition of metastatic meningioma, especially when treating patients with a history of intracranial meningioma.
MeSH term(s)	Endometrial Neoplasms/therapy ; Female ; Humans ; Lung ; Lung Neoplasms/therapy ; Meningeal Neoplasms/therapy ; Meningioma
Language	English
Publishing date	2021-07-12
Publishing country	United States
Document type	Case Reports ; Journal Article
ZDB-ID	2517183-5
ISSN	1941-5923 ; 1941-5923
ISSN (online)	1941-5923
ISSN	1941-5923
DOI	10.12659/AJCR.930708
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Article ; Online: Extrauterine epithelioid trophoblastic tumor arising in the ovary with multiple metastases: a case report.

Arafah, Maria A / Tulbah, Asma M / Al-Husaini, Hamed / Al-Sabban, Mohannad / Al-Shankiti, Hanan / Al-Badawi, Ismail A

International journal of surgical pathology

2015 Volume 23, Issue 4, Page(s) 339–344

Abstract: Epithelioid trophoblastic tumor is a neoplasm of the chorionic-type intermediate trophoblasts. It is considered a rare gestational trophoblastic disease and is frequently misdiagnosed as carcinoma. Extrauterine epithelioid trophoblastic tumor has been ... ...

Abstract	Epithelioid trophoblastic tumor is a neoplasm of the chorionic-type intermediate trophoblasts. It is considered a rare gestational trophoblastic disease and is frequently misdiagnosed as carcinoma. Extrauterine epithelioid trophoblastic tumor has been reported in multiple anatomical sites. We report a case of a 50-year-old woman who presented with abdominal pain and distension. Her initial β-human chorionic gonatotropin level was 806.7 IU/L. Imaging showed a large complex ovarian mass with peritoneal and subcapsular hepatic deposits as well as pulmonary nodules. Morphological features of the tumor and its immunohistochemical reactivity to CK8/18, CK7, p63, and CD10 were consistent with the diagnosis of an extrauterine epithelioid trophoblastic tumor arising from the ovary. The differential diagnoses, including other ovarian tumors, were ruled out on the basis of morphology and negative immunostaining to a relatively extended panel of antibodies. A prolonged follow up of these cases and the recognition of such rare tumors in unusual sites are crucial to the diagnosing pathologist and treating physician.
MeSH term(s)	Biomarkers, Tumor/analysis ; Epithelioid Cells/pathology ; Female ; Humans ; Immunohistochemistry ; Middle Aged ; Ovarian Neoplasms/pathology ; Trophoblastic Neoplasms/pathology
Chemical Substances	Biomarkers, Tumor
Language	English
Publishing date	2015-06
Publishing country	United States
Document type	Case Reports ; Journal Article
ZDB-ID	1336393-1
ISSN	1940-2465 ; 1066-8969
ISSN (online)	1940-2465
ISSN	1066-8969
DOI	10.1177/1066896915570661
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Article ; Online: Prevention and management of bone metastases in lung cancer: a review.

Al Husaini, Hamed / Wheatley-Price, Paul / Clemons, Mark / Shepherd, Frances A

Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer

2009 Volume 4, Issue 2, Page(s) 251–259

Abstract: Approximately 30 to 40% of patients with advanced lung cancer will develop bone metastases in the course of their disease, resulting in a significant negative impact on both morbidity and survival. Skeletal complications of bone metastases include pain, ... ...

Abstract	Approximately 30 to 40% of patients with advanced lung cancer will develop bone metastases in the course of their disease, resulting in a significant negative impact on both morbidity and survival. Skeletal complications of bone metastases include pain, pathologic fractures, spinal cord compression, and hypercalcemia. Total medical care costs are greater among patients with bone metastases who develop skeletal complications. A randomized phase III trial of the third generation bisphosphonate zoledronic acid has shown clinical benefit in the management of a subgroup of patients with bone metastases from lung cancer. Zoledronic acid treatment was associated with a reduction in both the risk of, and time to, a skeletal-related event. One of the markers of bone resorption, N-telopeptide, is both prognositic for development of skeletal-related events and predictive for benefit from zoledronic acid. In preclinical models, bisphosphonates have also demonstrated antitumor activity and are therefore currently being evaluated in adjuvant trials. Inhibition of the receptor activator of nuclear factor kappa B ligand-RANK pathway can reduce osteoclast-mediated bone resorption, and trials comparing receptor activator of nuclear factor kappa B ligand inhibitors with bisphosphonates are ongoing, including patients with lung cancer. In this article, we review the management of bone metastases and hypercalcemia as well as potential future directions for bone directed therapies in patients with lung cancer.
MeSH term(s)	Bone Neoplasms/drug therapy ; Bone Neoplasms/prevention & control ; Bone Neoplasms/secondary ; Humans ; Lung Neoplasms/drug therapy ; Lung Neoplasms/pathology ; Lung Neoplasms/prevention & control
Language	English
Publishing date	2009-02
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2432037-7
ISSN	1556-1380 ; 1556-0864
ISSN (online)	1556-1380
ISSN	1556-0864
DOI	10.1097/JTO.0b013e31819518fc
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Article ; Online: A detailed study of patients and tumor characteristics of epithelial ovarian cancer in Saudi women.

Al-Badawi, Ismail A / Munkarah, Adnan R / Tulbah, Asmaa / Babic, Inas I / Al Husaini, Hamed / Ahmad, Sarfraz

International journal of gynecological cancer : official journal of the International Gynecological Cancer Society

2012 Volume 23, Issue 3, Page(s) 456–460

Abstract: Background: The Saudi population is characterized by high parity and intermarriages that may impact ovarian carcinogenesis. Herein, we analyzed the tumor characteristics and outcomes in Saudi patients with epithelial ovarian cancer (EOC).: Methods: ... ...

Abstract	Background: The Saudi population is characterized by high parity and intermarriages that may impact ovarian carcinogenesis. Herein, we analyzed the tumor characteristics and outcomes in Saudi patients with epithelial ovarian cancer (EOC). Methods: Patients with EOC treated at King Faisal Specialist Hospital and Research Center during 1995-2007 were identified retrospectively through a review of their medical records. Patients' and tumor characteristics were collected including age at diagnosis, marital status, parity, histology, stage, treatment rendered, and follow-up data. Results: One hundred-ninety-three patients with EOC were identified in this cohort. The mean age of the patients was 55 ± 15 years, the mean ± SD body mass index was 27.0 ± 5.6 kg/m, and the median parity was approximately 7.0. Whereas 4 patients reported a family history of cancer, 164 women reported negative family history; and it was unknown in 27 cases. Tumor distribution by International Federation of Gynecology and Obstetrics stage was the following: 12 patients (6.2%) had stage I disease at diagnosis, 1 patient (0.5%) stage II disease, 130 patients (67.4%) stage III disease, 39 patients (20.2%) stage IV disease, and that of 11 patients (5.7%) was unknown. Information on residual disease after surgery was available on 98 patients with optimal debulking (<1 cm) achieved in 61 cases. Median progression-free survival from end of chemotherapy to recurrence/progression was 11.9 months (95% confidence interval, 9.4-15.2). Tumor histology, size of residual disease, and stage at diagnosis were significant prognostic factors. The patients' age, body mass index, tumor histology, and grade had no impact on survival. Conclusions: Patients presenting with advanced-stage disease are higher among Saudis than those reported in global literature. Despite high intermarriage rates, reported family history for related cancers was quite low in this cohort. Notably, this is the first study evaluating EOC in Saudi patients.
MeSH term(s)	Adenocarcinoma, Clear Cell/mortality ; Adenocarcinoma, Clear Cell/pathology ; Adenocarcinoma, Clear Cell/therapy ; Adenocarcinoma, Mucinous/mortality ; Adenocarcinoma, Mucinous/pathology ; Adenocarcinoma, Mucinous/therapy ; Adult ; Aged ; Aged, 80 and over ; Cystadenocarcinoma, Serous/mortality ; Cystadenocarcinoma, Serous/pathology ; Cystadenocarcinoma, Serous/therapy ; Endometrial Neoplasms/mortality ; Endometrial Neoplasms/pathology ; Endometrial Neoplasms/therapy ; Female ; Follow-Up Studies ; Humans ; Middle Aged ; Neoplasm Grading ; Neoplasm Staging ; Ovarian Neoplasms/mortality ; Ovarian Neoplasms/pathology ; Ovarian Neoplasms/therapy ; Prognosis ; Retrospective Studies ; Saudi Arabia ; Survival Rate ; Young Adult
Language	English
Publishing date	2012-11-30
Publishing country	England
Document type	Journal Article
ZDB-ID	1070385-8
ISSN	1525-1438 ; 1048-891X
ISSN (online)	1525-1438
ISSN	1048-891X
DOI	10.1097/IGC.0b013e318284aafe
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Article: Saudi lung cancer management guidelines 2017.

Jazieh, Abdul Rahman / Al Kattan, Khaled / Bamousa, Ahmed / Al Olayan, Ashwaq / Abdelwarith, Ahmed / Ansari, Jawaher / Al Twairqi, Abdullah / Al Fayea, Turki / Al Saleh, Khalid / Al Husaini, Hamed / Abdelhafiez, Nafisa / Mahrous, Mervat / Faris, Medhat / Al Omair, Ameen / Hebshi, Adnan / Al Shehri, Salem / Al Dayel, Foad / Bamefleh, Hanaa / Khalbuss, Walid /

Al Ghanem, Sarah / Loutfi, Shukri / Khankan, Azzam / Al Rujaib, Meshael / Al Ghamdi, Majed / Ibrahim, Nagwa / Swied, Abdulmonem / Al Kayait, Mohammad / Datario, Marie

Annals of thoracic medicine

2017 Volume 12, Issue 4, Page(s) 221–246

Abstract: Background: Lung cancer management is getting more complex due to the rapid advances in all aspects of diagnostic and therapeutic options. Developing guidelines is critical to help practitioners provide standard of care.: Methods: The Saudi Lung ... ...

Abstract	Background: Lung cancer management is getting more complex due to the rapid advances in all aspects of diagnostic and therapeutic options. Developing guidelines is critical to help practitioners provide standard of care. Methods: The Saudi Lung Cancer Guidelines Committee (SLCGC) multidisciplinary members from different specialties and from various regions and healthcare sectors of the country reviewed and updated all lung cancer guidelines with appropriate labeling of level of evidence. Supporting documents to help healthcare professionals were developed. Results: Detailed lung cancer management guidelines were finalized with appropriate resources for systemic therapy and short reviews highlighting important issues. Stage based disease management recommendation were included. A summary explanation for complex topics were included in addition to tables of approved systemic therapy. Conclusion: A multidisciplinary lung cancer guidelines was developed and will be disseminated across the country.
Language	English
Publishing date	2017-10-01
Publishing country	India
Document type	Journal Article
ZDB-ID	2241287-6
ISSN	1998-3557 ; 1817-1737
ISSN (online)	1998-3557
ISSN	1817-1737
DOI	10.4103/atm.ATM_92_17
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Article ; Online: Evaluation of adjuvant therapy in women with uterine papillary serous cancer.

Al Husaini, Hamed / Soudy, Hussein / Darwish, Alaa / Ahmed, Mohamed / Eltigani, Amin / Edesa, Wael / Abdelsalam, Mahmoud

Annals of Saudi medicine

2011 Volume 32, Issue 1, Page(s) 27–31

Abstract: Background and objective: Uterine papillary serous cancer (UPSC) represents only 10% of all uterine cancers and is associated with a significantly worse prognosis compared with other histological types of endometrial cancers. It closely resembles the ... ...

Abstract	Background and objective: Uterine papillary serous cancer (UPSC) represents only 10% of all uterine cancers and is associated with a significantly worse prognosis compared with other histological types of endometrial cancers. It closely resembles the behavior of ovarian carcinoma. Design and setting: Retrospective study in a referral center covering period from February 1989 to January 2009. Patients and methods: Eighteen patients who underwent definitive surgery followed by adjuvant therapy-platinum-based chemotherapy, radiotherapy, or both-were reviewed. Median age was 62 years (range, 52-76 years). All patients underwent total abdominal hysterectomy and salpingo-oophorectomy. Positive lymph nodes were found in 4 of 7 patients who underwent lymph node sampling/dissection. Seven patients had stage I/II disease, whereas 11 patients had stage III disease. Six patients received chemotherapy, 5 patients received radiation therapy, while 7 patients received both chemotherapy and radiation therapy. Result: Median follow-up was 27 months. The median survival and relapse-free survival were 33 and 23 months, respectively. Eight patients were alive and free of disease, of whom 5 patients were stage I/II and 4 patients were stage III. Distant metastasis was the most common site of relapse. Early stage (I/II) was associated with significant improvement in relapse-free survival (RFS) and overall survival (OS) (P=.004 and P=.05, respectively). The combined-modality treatment including chemotherapy-radiotherapy showed statistically significant improvement in RFS (P=.012), while the improvement in OS did not reach statistical significance (P=.12). Conclusion: This study indicates that postoperative combined treatment with chemotherapy and radiation therapy plays a role in the management of UPSC by improving RFS. Distant metastasis remains the major site of relapse. Future studies using combined-modality therapy are needed to improve the outcome in patients with UPSC.
MeSH term(s)	Aged ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Chemotherapy, Adjuvant ; Combined Modality Therapy ; Cystadenocarcinoma, Serous/therapy ; Disease-Free Survival ; Endometrial Neoplasms/therapy ; Female ; Humans ; Hysterectomy ; Middle Aged ; Neoplasm Metastasis ; Neoplasm Recurrence, Local ; Ovariectomy ; Radiotherapy, Adjuvant ; Retrospective Studies ; Salpingectomy ; Treatment Outcome
Language	English
Publishing date	2011-12-07
Publishing country	Saudi Arabia
Document type	Journal Article
ZDB-ID	639014-6
ISSN	0975-4466 ; 0256-4947
ISSN (online)	0975-4466
ISSN	0256-4947
DOI	10.5144/0256-4947.2012.27
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Article ; Online: Lynch Syndrome Identification in Saudi Cohort of Endometrial Cancer Patients Screened by Universal Approach.

Bu, Rong / Siraj, Abdul K / Parvathareddy, Sandeep Kumar / Iqbal, Kaleem / Azam, Saud / Qadri, Zeeshan / Al-Rasheed, Maha / Haqawi, Wael / Diaz, Mark / Alobaisi, Khadija / Annaiyappanaidu, Padmanaban / Siraj, Nabil / AlHusaini, Hamed / Alomar, Osama / Al-Badawi, Ismail A / Al-Dayel, Fouad / Al-Kuraya, Khawla S

International journal of molecular sciences

2022 Volume 23, Issue 20

Abstract: Lynch syndrome (LS) is the most common cause of inherited endometrial cancer (EC). The prevalence and molecular characteristic of LS in Middle Eastern women with EC have been underexplored. To evaluate the frequency of LS in a cohort of EC patients from ... ...

Abstract	Lynch syndrome (LS) is the most common cause of inherited endometrial cancer (EC). The prevalence and molecular characteristic of LS in Middle Eastern women with EC have been underexplored. To evaluate the frequency of LS in a cohort of EC patients from Saudi Arabia, a total of 436 EC cases were screened utilizing immunohistochemistry (IHC),
MeSH term(s)	Humans ; Female ; Colorectal Neoplasms, Hereditary Nonpolyposis/epidemiology ; Colorectal Neoplasms, Hereditary Nonpolyposis/genetics ; Colorectal Neoplasms, Hereditary Nonpolyposis/pathology ; MutS Homolog 2 Protein/genetics ; DNA Mismatch Repair/genetics ; Saudi Arabia/epidemiology ; Germ-Line Mutation/genetics ; DNA Methylation ; Endometrial Neoplasms/epidemiology ; Endometrial Neoplasms/genetics ; Endometrial Neoplasms/pathology ; Microsatellite Instability
Chemical Substances	MutS Homolog 2 Protein (EC 3.6.1.3)
Language	English
Publishing date	2022-10-14
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2019364-6
ISSN	1422-0067 ; 1422-0067 ; 1661-6596
ISSN (online)	1422-0067
ISSN	1422-0067 ; 1661-6596
DOI	10.3390/ijms232012299
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Article ; Online: Evaluation of adjuvant therapy in women with uterine papillary serous cancer

Hamed Al Husaini / Hussein Soudy / Alaa Darwish / Mohamed Ahmed / Amin Eltigani / Wael Edesa / Mahmoud Abdelsalam

Annals of Saudi Medicine, Vol 32, Iss 1, Pp 27-

2012 Volume 31

Abstract: BACKGROUND AND OBJECTIVE: Uterine papillary serous cancer (UPSC) represents only 10% of all uterine cancers and is associated with a significantly worse prognosis compared with other histological types of endometrial cancers. It closely resembles the ... ...

Abstract	BACKGROUND AND OBJECTIVE: Uterine papillary serous cancer (UPSC) represents only 10% of all uterine cancers and is associated with a significantly worse prognosis compared with other histological types of endometrial cancers. It closely resembles the behavior of ovarian carcinoma. DESIGN AND SETTING: Retrospective study in a referral center covering period from February 1989 to January 2009. PATIENTS AND METHODS: Eighteen patients who underwent definitive surgery followed by adjuvant therapy—platinum-based chemotherapy, radiotherapy, or both—were reviewed. Median age was 62 years (range, 52–76 years). All patients underwent total abdominal hysterectomy and salpingo-oophorectomy. Positive lymph nodes were found in 4 of 7 patients who underwent lymph node sampling/dissection. Seven patients had stage I/II disease, whereas 11 patients had stage III disease. Six patients received chemotherapy, 5 patients received radiation therapy, while 7 patients received both chemotherapy and radiation therapy. RESULT: Median follow-up was 27 months. The median survival and relapse-free survival were 33 and 23 months, respectively. Eight patients were alive and free of disease, of whom 5 patients were stage I/II and 4 patients were stage III. Distant metastasis was the most common site of relapse. Early stage (I/II) was associated with significant improvement in relapse-free survival (RFS) and overall survival (OS) (P=.004 and P=.05, respectively). The combined-modality treatment including chemotherapy-radiotherapy showed statistically significant improvement in RFS (P=.012), while the improvement in OS did not reach statistical significance (P=.12). CONCLUSION: This study indicates that postoperative combined treatment with chemotherapy and radiation therapy plays a role in the management of UPSC by improving RFS. Distant metastasis remains the major site of relapse. Future studies using combined-modality therapy are needed to improve the outcome in patients with UPSC.
Keywords	Medicine ; R
Subject code	610 ; 616
Language	English
Publishing date	2012-01-01T00:00:00Z
Publisher	King Faisal Specialist Hospital and Research Centre
Document type	Article ; Online
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Article ; Online: Pure dysgerminoma of the ovary: a single institutional experience of 65 patients.

A L Husaini, Hamed / Soudy, Hussein / El Din Darwish, Alaa / Ahmed, Mohamed / Eltigani, Amin / A L Mubarak, Mustafa / Sabaa, Amal Abu / Edesa, Wael / A L-Tweigeri, Taher / Al-Badawi, Ismail A

Medical oncology (Northwood, London, England)

2012 Volume 29, Issue 4, Page(s) 2944–2948

Abstract: Ovarian dysgerminomas are rare entity and account for only about 2% of all malignant ovarian neoplasm. The aim of this study was to evaluate the clinicopathologic characteristics, treatment, long-term survival, and fertility outcome of women diagnosed ... ...

Abstract	Ovarian dysgerminomas are rare entity and account for only about 2% of all malignant ovarian neoplasm. The aim of this study was to evaluate the clinicopathologic characteristics, treatment, long-term survival, and fertility outcome of women diagnosed with ovarian dysgerminoma at our institution. Sixty-five women with histologically proven pure ovarian dysgerminoma were identified in this retrospective study. They were treated at King Faisal Specialist Hospital, Riyadh; Saudi Arabia between 1976 and 2010. The median age was 20 years. The most frequent symptoms at presentation were abdominal pain and abdominal/pelvic mass. Thirty-three patients (50.7%) presented with stage I, 2 (3.1%) had stage II, 22 (33.8%) had stage III, and 4 (6.2%) had stage IV (4 unknown stage). Unilateral oophorectomy was performed in 50 patients (76.9%) while bilateral oophorectomy±hysterectomy was done in 12 patients (18.4%). Three patients had biopsy only. Forty patients (61.5%) received only chemotherapy, and 4 patients (6.2%) received radiotherapy alone. Recurrence was observed in 6 patients (9.2%). With median follow-up of 54 months, the 5-year disease-free survival (DFS) and overall survival (OS) were 88 and 95%, respectively. On univariate analysis, adjuvant chemotherapy was independent better prognostic factor for DFS (HR, 0.09; 95% CI, 0.01-0.84; P=0.034). Of the 50 patients treated with fertility-sparing surgery, 16 patients (32%) achieved pregnancy with 14 live births. Patients with pure ovarian dysgerminoma have excellent long-term outcome. There is no difference at outcome between fertility-sparing and nonconservative surgeries. Adjuvant chemotherapy was associated with significant improvement in DFS. It is possible to maintain good reproductive function after conservative surgery followed by chemotherapy in our series.
MeSH term(s)	Adolescent ; Adult ; Aged ; Dysgerminoma/mortality ; Dysgerminoma/pathology ; Dysgerminoma/therapy ; Female ; Humans ; Middle Aged ; Neoplasm Recurrence, Local ; Neoplasm Staging ; Ovarian Neoplasms/mortality ; Ovarian Neoplasms/pathology ; Ovarian Neoplasms/therapy
Language	English
Publishing date	2012-03-10
Publishing country	United States
Document type	Journal Article
ZDB-ID	1201189-7
ISSN	1559-131X ; 0736-0118 ; 1357-0560
ISSN (online)	1559-131X
ISSN	0736-0118 ; 1357-0560
DOI	10.1007/s12032-012-0194-z
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Article ; Online: A randomized, phase 2 study comparing pemetrexed plus best supportive care versus best supportive care as maintenance therapy after first-line treatment with pemetrexed and cisplatin for advanced, non-squamous, non-small cell lung cancer.

Mubarak, Nabil / Gaafar, Rabab / Shehata, Samir / Hashem, Tarek / Abigeres, Dani / Azim, Hamdy A / El-Husseiny, Gamal / Al-Husaini, Hamed / Liu, Zhixin

BMC cancer

2012 Volume 12, Page(s) 423

Abstract: Background: Maintenance therapy for non-small cell lung cancer (NSCLC) aims to extend disease control after first-line chemotherapy with active and well-tolerated agents. The utility of continuation maintenance therapy requires further research.: ... ...

Abstract	Background: Maintenance therapy for non-small cell lung cancer (NSCLC) aims to extend disease control after first-line chemotherapy with active and well-tolerated agents. The utility of continuation maintenance therapy requires further research. Methods: This multicenter, randomized, phase 2 study compared continuation maintenance therapy with pemetrexed (500 mg/m2 every 21 days) and best supportive care (BSC) versus BSC alone in patients with advanced, non-squamous NSCLC who had not progressed after 4 cycles of induction chemotherapy with pemetrexed (500 mg/m2) and cisplatin (75 mg/m2). The primary endpoint was progression-free survival (PFS) from randomization, was analyzed using a Cox model, stratified for the tumor response at the end of induction therapy, at a one-sided alpha of 0.2. Secondary endpoints: response and disease control rates, overall survival (OS), one year survival rates, and treatment-emergent adverse events (TEAEs). Results: A total of 106 patients commenced induction therapy, of whom 55 patients were randomized to maintenance pemetrexed/BSC (n = 28) or BSC (n = 27). Although the median PFS time for maintenance phase for both arms was 3.2 months, the one-sided p-value for the PFS HR comparison was less than the prespecified limit of 0.2 (HR = 0.76, two-sided 95% confidence interval [CI]: 0.42 to 1.37; one-sided p-value = 0.1815), indicating that PFS was sufficiently long in the pemetrexed/BSC arm to warrant further investigation. Similar PFS results were observed for the overall study period (induction plus maintenance) and when the PFS analysis was adjusted for sex, baseline disease stage, and the ECOG PS prior to randomization. The median OS for the maintenance phase was 12.2 months (95%CI: 5.6 to 20.6) for the pemetrexed/BSC arm and 11.8 months (95% CI: 6.3 to 25.6) for BSC arm. The one-year survival probabilities were similar for both arms for the maintenance phase and the overall study period. Both the induction and continuation maintenance therapies were generally well-tolerated, and similar proportion of patients in each arm experienced at least 1 grade 3/4 TEAE (pemetrexed/BSC, 17.9%; BSC, 18.5%). Conclusions: Continuation pemetrexed maintenance therapy resulted in promising PFS with an acceptable safety profile in a Middle Eastern population with advanced non-squamous NSCLC and is worthy of further investigation. Trial registration: NCT00606021.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Non-Small-Cell Lung/mortality ; Carcinoma, Non-Small-Cell Lung/pathology ; Cisplatin/administration & dosage ; Female ; Glutamates/administration & dosage ; Guanine/administration & dosage ; Guanine/analogs & derivatives ; Humans ; Lung Neoplasms/drug therapy ; Lung Neoplasms/mortality ; Lung Neoplasms/pathology ; Male ; Middle Aged ; Neoplasm Staging ; Pemetrexed ; Treatment Outcome ; Young Adult
Chemical Substances	Glutamates ; Pemetrexed (04Q9AIZ7NO) ; Guanine (5Z93L87A1R) ; Cisplatin (Q20Q21Q62J)
Language	English
Publishing date	2012-09-24
Publishing country	England
Document type	Clinical Trial, Phase II ; Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2041352-X
ISSN	1471-2407 ; 1471-2407
ISSN (online)	1471-2407
ISSN	1471-2407
DOI	10.1186/1471-2407-12-423
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