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Metronomic oral cyclosphosphamide as third-line systemic treatment or beyond in patients with inoperable locoregionally advanced recurrent or metastatic nasopharyngeal carcinoma.

Abstract There is no standard third-line or further systemic treatment for patients with inoperable locoregionally advanced recurrent or metastatic nasopharyngeal carcinoma (NPC). Metronomic oral cyclophosphamide provides an acceptable and cheap option for these heavily pretreated patients who had limited choices. We conducted a prospective phase II single-arm open-label study of metronomic oral cyclophosphamide. Patients with locoregionally advanced recurrent inoperable (rT3/T4, rN2-N3b) or metastatic (rM1) NPC who had Eastern Cooperative Oncology Group (ECOG) performance status (PS) (0-2) and had progressed after at least 2 lines of palliative systemic chemotherapy were eligible. They received oral cyclophosphamide between 50 and 150 mg once daily until progressive disease or unacceptable toxicity. Objective response rate (ORR), disease control rate (DCR), biochemical response (two consecutive declines of plasma EBV DNA after treatment), progression-free survival (PFS), overall survival (OS), and safety profiles were evaluated. A total of 56 patients were recruited. Thirty-three, 13, 6, 3, and 1 patients received cyclophosphamide as 3rd, 4th, 5th, 6th, and 7th line of therapy respectively. After a median follow-up of 9.95 months (range 1.76-59.51 months), the ORR was 8.9% and the DCR was 57.1%. The median PFS and OS were 4.47 and 9.20 months, respectively. Those with PS 1 had longer median PFS (5.49 months) compared to those with PS 2 (3.75 months, P = .011). Besides, those who had locoregionally recurrent disease had better PFS (8.97 months, 95% CI, 0.53-17.41 months) compared to those who had distant metastases (4.14 months, 95% CI, 2.53-5.75 months, P = .020). Multivariable analysis revealed that PS 1 (vs 2) (P = .020) and locoregional recurrence (vs metastasis) (P = .029) were the only significant independent prognostic factors of PFS. Around 16 (28.6%) patients developed grade ≥3 adverse events, including malaise (5.4%), hematological (8.9%), gastrointestinal (3.6%), feverish (3.6%), and hemorrhagic (1.8%) events. The median cost of the whole drug treatment was 51.65 US dollars (USD) (range 4.15-142.75 USD) (1 USD = 7.8 HK dollars [HKD]). Metronomic oral cyclophosphamide is an acceptable third-line or beyond systemic therapy for locoregionally advanced recurrent or metastatic NPC with acceptable toxicity and limited financial burden.
PMID
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Authors

Mayor MeshTerms
Keywords
Journal Title medicine
Publication Year Start




PMID- 28403082
OWN - NLM
STAT- MEDLINE
DA  - 20170413
DCOM- 20170428
LR  - 20170429
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Linking)
VI  - 96
IP  - 15
DP  - 2017 Apr
TI  - Metronomic oral cyclosphosphamide as third-line systemic treatment or beyond in
      patients with inoperable locoregionally advanced recurrent or metastatic
      nasopharyngeal carcinoma.
PG  - e6518
LID - 10.1097/MD.0000000000006518 [doi]
AB  - There is no standard third-line or further systemic treatment for patients with
      inoperable locoregionally advanced recurrent or metastatic nasopharyngeal
      carcinoma (NPC). Metronomic oral cyclophosphamide provides an acceptable and
      cheap option for these heavily pretreated patients who had limited choices. We
      conducted a prospective phase II single-arm open-label study of metronomic oral
      cyclophosphamide. Patients with locoregionally advanced recurrent inoperable
      (rT3/T4, rN2-N3b) or metastatic (rM1) NPC who had Eastern Cooperative Oncology
      Group (ECOG) performance status (PS) (0-2) and had progressed after at least 2
      lines of palliative systemic chemotherapy were eligible. They received oral
      cyclophosphamide between 50 and 150 mg once daily until progressive disease or
      unacceptable toxicity. Objective response rate (ORR), disease control rate (DCR),
      biochemical response (two consecutive declines of plasma EBV DNA after
      treatment), progression-free survival (PFS), overall survival (OS), and safety
      profiles were evaluated. A total of 56 patients were recruited. Thirty-three, 13,
      6, 3, and 1 patients received cyclophosphamide as 3rd, 4th, 5th, 6th, and 7th
      line of therapy respectively. After a median follow-up of 9.95 months (range
      1.76-59.51 months), the ORR was 8.9% and the DCR was 57.1%. The median PFS and OS
      were 4.47 and 9.20 months, respectively. Those with PS 1 had longer median PFS
      (5.49 months) compared to those with PS 2 (3.75 months, P = .011). Besides, those
      who had locoregionally recurrent disease had better PFS (8.97 months, 95% CI,
      0.53-17.41 months) compared to those who had distant metastases (4.14 months, 95%
      CI, 2.53-5.75 months, P = .020). Multivariable analysis revealed that PS 1 (vs 2)
      (P = .020) and locoregional recurrence (vs metastasis) (P = .029) were the only
      significant independent prognostic factors of PFS. Around 16 (28.6%) patients
      developed grade >/=3 adverse events, including malaise (5.4%), hematological
      (8.9%), gastrointestinal (3.6%), feverish (3.6%), and hemorrhagic (1.8%) events. 
      The median cost of the whole drug treatment was 51.65 US dollars (USD) (range
      4.15-142.75 USD) (1 USD = 7.8 HK dollars [HKD]). Metronomic oral cyclophosphamide
      is an acceptable third-line or beyond systemic therapy for locoregionally
      advanced recurrent or metastatic NPC with acceptable toxicity and limited
      financial burden.
FAU - Lee, Victor H F
AU  - Lee VH
AD  - Department of Clinical Oncology, Li Ka Shing Faculty of Medicine, The University 
      of Hong Kong, Hong Kong.
FAU - Kwong, Dora L W
AU  - Kwong DL
FAU - Lam, Ka-On
AU  - Lam KO
FAU - Lai, Yu-Ching
AU  - Lai YC
FAU - Li, Yun
AU  - Li Y
FAU - Tong, Chi-Chung
AU  - Tong CC
FAU - Ho, Patty P Y
AU  - Ho PP
FAU - Chan, Wing-Lok
AU  - Chan WL
FAU - Wong, Lai-San
AU  - Wong LS
FAU - Leung, Dennis K C
AU  - Leung DK
FAU - Chan, Sum-Yin
AU  - Chan SY
FAU - Chan, Fong-Ting
AU  - Chan FT
FAU - Leung, To-Wai
AU  - Leung TW
FAU - Lee, Anne W M
AU  - Lee AW
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 0 (Antineoplastic Agents, Alkylating)
RN  - 8N3DW7272P (Cyclophosphamide)
RN  - Nasopharyngeal carcinoma
SB  - AIM
SB  - IM
MH  - Administration, Metronomic
MH  - Administration, Oral
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents, Alkylating/*administration & dosage/economics
MH  - Cyclophosphamide/*administration & dosage/economics
MH  - Disease Progression
MH  - Disease-Free Survival
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nasopharyngeal Neoplasms/*drug therapy/mortality/pathology
MH  - Neoplasm Metastasis
MH  - Neoplasm Recurrence, Local/*drug therapy/mortality/pathology
MH  - Prospective Studies
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC5403079
EDAT- 2017/04/14 06:00
MHDA- 2017/04/14 06:00
CRDT- 2017/04/14 06:00
AID - 10.1097/MD.0000000000006518 [doi]
AID - 00005792-201704140-00015 [pii]
PST - ppublish
SO  - Medicine (Baltimore). 2017 Apr;96(15):e6518. doi: 10.1097/MD.0000000000006518.

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