Cancer Research and Treatment

Original Articles

An Open-Label, Randomized, Parallel, Phase III Trial Evaluating the Efficacy and Safety of Polymeric Micelle-Formulated Paclitaxel Compared to Conventional Cremophor EL-Based Paclitaxel for Recurrent or Metastatic HER2-Negative Breast Cancer: In Hae Park, Joo Hyuk Sohn, Sung Bae Kim, Keun Seok Lee, Joo Seop Chung, Soo Hyeon Lee, Tae You Kim, Kyung Hae Jung, Eun Kyung Cho, Yang Soo Kim, Hong Suk Song, Jae Hong Seo, Hun Mo Ryoo, Sun Ah Lee, So Young Yoon, Chul Soo Kim, Yong Tai Kim, Si Young Kim, Mi Ryung Jin, Jungsil Ro; Cancer Res Treat. 2017;49(3):569-577. Published online September 12, 2016; DOI: https://doi.org/10.4143/crt.2016.289

Purpose
Genexol-PM is a Cremophor EL–free formulation of low-molecular-weight, non-toxic, and biodegradable polymeric micelle-bound paclitaxel. We conducted a phase III study comparing the clinical efficacy and toxicity of Genexol-PM with conventional paclitaxel (Genexol).
Materials and Methods
Patients were randomly assigned (1:1) to receive Genexol-PM 260 mg/m² or Genexol 175 mg/m² intravenously every 3 weeks. The primary outcome was the objective response rate (ORR).
Results
The study enrolled 212 patients, of whom 105 were allocated to receive Genexol-PM. The mean received dose intensity of Genexol-PM was 246.8±21.3 mg/m² (95.0%), and that of Genexol was 168.3±10.6 mg/m² (96.2%). After a median follow-up of 24.5 months (range, 0.0 to 48.7 months), the ORR of Genexol-PM was 39.1% (95% confidence interval [CI], 31.2 to 46.9) and the ORR of Genexol was 24.3% (95% CI, 17.5 to 31.1) (p_{non-inferiority}=0.021, p_superiority=0.016). The two groups did not differ significantly in overall survival (28.8 months for Genexol-PM vs. 23.8 months for Genexol; p=0.52) or progression-free survival (8.0 months for Genexol-PM vs. 6.7 months for Genexol; p=0.26). In both groups, the most common toxicities were neutropenia, with 68.6% occurrence in the Genexol-PM group versus 40.2% in the Genexol group (p < 0.01). The incidences of peripheral neuropathy of greater than grade 2 did not differ significantly between study treatments.
Conclusion
Compared with standard paclitaxel, Genexol-PM demonstrated non-inferior and even superior clinical efficacy with a manageable safety profile in patients with metastatic breast cancer.

Citations

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Clinical Usefulness of Hydromorphone-OROS in Improving Sleep Disturbances in Korean Cancer Patients: A Multicenter, Prospective, Open-Label Study: Seong Hoon Shin, Ho Sup Lee, Yang Soo Kim, Young Jin Choi, Sung Hyun Kim, Hyuk Chan Kwon, Sung Yong Oh, Jung Hun Kang, Chang Hak Sohn, Sang Min Lee, Jin Ho Baek, Young Joo Min, Choongrak Kim, Joo Seop Chung; Cancer Res Treat. 2014;46(4):331-338. Published online July 21, 2014; DOI: https://doi.org/10.4143/crt.2013.130

Abstract PDF PubReader ePub

Purpose
To evaluate the efficacy of hydromorphone-OROS (HM-OROS) in reducing sleep disturbance and relieving cancer pain. Materials and Methods One hundred twenty cancer patients with pain (numeric rating scale [NRS] ≥ 4) and sleep disturbance (NRS ≥ 4) were evaluated. The initial HM-OROS dosing was based on previous opioid dose (HM-OROS:oral morphine=1:5). Dose adjustment of the study drug was permitted at the investigator’s discretion. Pain intensity, number of breakthrough pain episodes, and quality of sleep were evaluated. Results A total of 120 patients received at least one dose of HM-OROS; 74 of them completed the final assessment. Compared to the previous opioids, HM-OROS reduced the average pain NRS from 5.3 to 4.1 (p < 0.01), worst pain NRS from 6.7 to 5.4 (p < 0.01), sleep disturbance NRS from 5.9 to 4.1 (p < 0.01), incidence of breakthrough pain at night from 2.63 to 1.53 times (p < 0.001), and immediate-release opioids use for the management of breakthrough pain from 0.83 to 0.39 times per night (p = 0.001). Of the 74 patients who completed the treatment, 83.7% indicated that they preferred HM-OROS to the previous medication. The adverse events (AEs) were somnolence, asthenia, constipation, dizziness, and nausea. Conclusion HM-OROS was efficacious in reducing cancer pain and associated sleep disturbances. The AEs were manageable.

Citations

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Randomized, Multicenter, Phase III Trial of Heptaplatin 1-hour Infusion and 5-Fluorouracil Combination Chemotherapy Comparing with Cisplatin and 5-Fluorouracil Combination Chemotherapy in Patients with Advanced Gastric Cancer: Kyung Hee Lee, Myung Soo Hyun, Hoon-Kyo Kim, Hyung Min Jin, Jinmo Yang, Hong Suk Song, Young Rok Do, Hun Mo Ryoo, Joo Seop Chung, Dae Young Zang, Ho-Yeong Lim, Jong Youl Jin, Chang Yeol Yim, Hee Sook Park, Jun Suk Kim, Chang Hak Sohn, Soon Nam Lee; Cancer Res Treat. 2009;41(1):12-18. Published online March 31, 2009; DOI: https://doi.org/10.4143/crt.2009.41.1.12

Abstract PDF PubReader ePub

Purpose

Heptaplatin (Sunpla) is a cisplatin derivative. A phase IIb trial using heptaplatin resulted in a 34% response rate with mild nephrotoxicity. We conducted a randomized phase III trial of heptaplatin plus 5-FU compared with cisplatin plus 5-FU in patients with advanced gastric cancer.

Materials and Methods

One hundred seventy-four patients (heptaplatin, n=88; cisplatin, n=86) from 13 centers were enrolled. The eligibility criteria were as follows: patients with pathologically-proven adenocarcinoma, chemonaive patients, or patients who had received only single adjuvant chemotherapy, and who had a measurable or evaluable lesion. On day 1, heptaplatin (400 mg/m²) or cisplatin (60 mg/m²) was given over 1 hour with 5-FU (1 gm/m²) on days 1~5 every 4 weeks.

Results

At the time of survival analysis, the median overall survival was 7.3 months in the 5-FU + heptaplatin (FH) arm and 7.9 months in the 5-FU + cisplatin (FP) arm (p=0.24). Of the FH patients, 34.2% (complete response [CR], 1.3%; partial response [PR], 32.9%) experienced a confirmed objective response compared with 35.9% (CR 0%, PR 35.9%) of FP patients (p=0.78). The median-time-to-progression was 2.5 months in the FH arm and 2.3 months in the FP arm. The incidence of neutropenia was higher with FP (28%) than with FH (16%; p=0.06); grade 3~4 nausea and vomiting were more frequent in the FP than in the FH arm (p=0.01 and p=0.05, respectively). The incidence of increased proteinuria and creatininemia was higher with FH than with FP; however, there was no statistical difference. There were no treatment-related deaths.

Conclusion

Heptaplatin showed similar effects to cisplatin when combined with 5-FU in advanced gastric cancer patients with tolerable toxicities.

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Docetaxel and Cisplatin Combination Chemotherapy in Patients with Squamous Cell Carcinomas of the Head and Neck: Jung Hyun Lee, Kyung Woo Lee, Young Jin Choi, Jae Hoon Choi, Ho Jin Shin, Joo Seop Chung, Goon Jae Cho, Byung Ju Lee, Soo Geun Wang; Cancer Res Treat. 2003;35(3):261-266. Published online June 30, 2003; DOI: https://doi.org/10.4143/crt.2003.35.3.261

Abstract PDF

PURPOSE
The objective of this phase II study was to assess the clinical antitumor activity and toxicities of docetaxel and cisplatin chemotherapy, in patients with locally advanced and metastatic, recurrent squamous cell carcinomas of the head and neck (SCCHN). MATERIALS AND METHODS: All eligible patients with locally advanced and metastatic, recurrent SCCHN had received two courses of chemotherapy followed by repeated head and neck examinations and computed tomography. Patients who had received prior chemotherapy with taxanes were ineligible. If the patients achieved a response (either CR or PR), they received one more course of chemotherapy prior to undergoing definitive local treatment. The combination chemotherapy consisted of docetaxel, 70 mg/m2, and cisplatin, 75 mg/m2, on day 1, with the cycles repeated every 3~4 weeks. RESULTS: All 32 patients were assessable for response and toxicity analyses. The most common grade 3/4 adverse event was neutropenia, which occurred in 11% of cases. No febrile neutropenia was noticed. The other grade 3/4 adverse events included: anemia (2%) and stomatitis (3%). The response rate in patients with locally advanced cancer was 19/21 (90%). Fifteen patients (71%) achieved a CR and 4 (19%) a PR. Out of the 4 patients presenting with a distant metastatic disease, 1 each achieved CR and PR, with 2 stable disease (SD). Out of the 7 patients with a recurrence at a distant site, 1 each achieved PR and SD, and 5 (71%) had a progression of the disease (PD). The overall response rate was 22/32 (69%).
CONCLUSION
Docetaxel plus cisplatin is an effective regimen with an acceptable toxicity profile. This regimen may offer high antitumor activity on short outpatient administration, with a low incidence of severe toxicity.

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The Analysis of Induction Chemotherapy Using Docetaxel and Platinum in Treatment of Hypopharyngeal Carcinoma
Jongseung Kim, Kyengsuk Lee, Byungeon Hwang, Sangho Lim, Sunho Ryu, Ilwoo Ha, Eun Jung Lee, Kihwan Hong, Yunsu Yang
Korean Journal of Otorhinolaryngology-Head and Neck Surgery.2010; 53(11): 706. CrossRef
The Efficacy of an Induction Chemotherapy Combination with Docetaxel, Cisplatin, and 5-FU Followed by Concurrent Chemoradiotherapy in Advanced Head and Neck Cancer
Jae-Sook Ahn, Sang-Hee Cho, Ok-Ki Kim, Joon-Kyoo Lee, Deok-Hwan Yang, Yeo-Kyeoung Kim, Je-Jung Lee, Sang-Chul Lim, Hyeoung-Joon Kim, Woong-Ki Chung, Ik-Joo Chung
Cancer Research and Treatment.2007; 39(3): 93. CrossRef

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Combination Chemotherapy with Etoposide, Ifosfamide, and Cisplatin (VIP) in Small Cell Lung Cancer: Goon Jae Cho, Joo Seop Chung, Ihm Soo Kwak, Ha Yeon Rha; J Korean Cancer Assoc. 1999;31(3):539-547.

Abstract PDF: PURPOSE
Combination chemotherapy has shown promising activity in small cell lung cancer (SCLC). This study was perfonned to determine the efficacy of the combination chemotherapy with etoposide, ifosfamide and cisplatin (VIP) in previously untreated patients with SCLC.
MATERIALS AND METHODS
Patients with SCLC were treated with etoposide (75 mg/m iv. D1-4), ifosfamide (1200 mg/m iv. Dl-4 with mesna) and cisplatin (20 mg/m iv. D1-4). The treatment was repeated every 3 weeks for 6 cycles in principle. Thoracic radiotherapy was administered to patients with limited disease (LD) of SCLC after initial 2 or 3 cycles of chemotherapy subsequently. Praphylactic cranial irradiation (PCI) was given to complete responders of SCLC.
RESULTS
From April 1996 through June 1998, 42 patients were included, but 32 were eligible for the study (4 refused of treatment, 2 lost in follow-up, and 4 combined with other disease). The median age was 62 years (range, 42-74). Twelve patients had LD and 20 patients were with extended disease (ED). Complete response (CR) rate was 34% (LD 58%, ED 20%) and overall response rate was 72% (LD 83%, ED 65%). The median duration of response was 28 weeks (38 weeks in LD, 24 weeks in ED, P=0.016) With the median follow-up period of 65 weeks (6-134 weeks), overall median survival was 43 weeks (56 weeks in LD, 34 weeks in ED, P 0.001), and the median disease free survival (DFS) of eleven CR patients was 16 weeks. Stage, performance, and LDH level were significant prognostic factom (P 0.011, 0.002, 0.043, respectively), but sex and age did not affect the outcome significantly. The hematologic side effects (WHO grade 2) of evaluable 152 cycles of chemotherapy were leukopenia (53%), thrombocytopenia (31%) and anemia (16%); and nonhematologic side effects (WHO grade >2) were alopecia (84%), nausea/vomiting (45%) and stomatitis (19%).
CONCLUSION
It appears that VIP combination chemotherapy is a safe, effective and well tolerated regimen for the patients with SCLC.

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