Risk Associated with Severe Hematological Toxicity in Patients with Urothelial Cancer Receiving Combination Chemotherapy of Gemcitabine and Cisplatin

Introduction: Combination chemotherapy of gemcitabine and cisplatin (GC) is the standard treatment for patients with urothelial cancer (UC). However, hematological toxicity is a major side effect of GC therapy in patients with UC. In particular, discontinuation of the GC therapy is associated to adverse events such as hematological toxicity. Some studies have reported general risk factors of hematological toxicity such as age. However, little is known about risk factors for GC therapy-associated hematological toxicity in patients with UC. Objective: We aimed to identify risk factors for hematological toxicity in patients with UC receiving GC therapy. Methods: We performed a retrospective evaluation of the data of 128 patients with UC who received GC therapy. The study end point was defined as the occurrence of grade 4 neutropenia and grade ≥3 thrombocytopenia. Logistic regression analysis was used to determine risk factors that were significantly associated with neutropenia and thrombocytopenia. Results: In total, 62 (48.4%) patients experienced grade 4 neutropenia, and 27 (21.1%) patients experienced grade ≥3 thrombocytopenia. In the multivariate analysis, performance status (PS) ≥1 (odds ratio [OR] 3.764, 95% confidence interval [CI] 1.410–10.047, p = 0.008) and neutrophil count (OR 0.648, 95% CI 0.468–0.898, p = 0.009) were significantly associated with grade 4 neutropenia. Platelet count (PLT) (OR 0.896, 95% CI 0.832–0.966, p = 0.004) and potassium (K) level (OR 6.966, 95% CI 1.313–36.989, p = 0.023) were also significantly associated with grade ≥3 thrombocytopenia. Conclusions: PS ≥ 1, neutrophil count, PLT, and K level were important risk factors for GC therapy-induced hematological toxicity in patients with UC. To continue GC therapy, further management systems by hematological toxicity risk factors for patients with UC will be required.

Download Full-text

Age-Based Comparison of Hematological Toxicity in Patients with Lung Cancer

Oncology ◽

10.1159/000507864 ◽

2020 ◽

Vol 98 (11) ◽

pp. 771-778

Author(s):

Yuki Sakai ◽

Qiliang Zhou ◽

Yoshifumi Matsumoto ◽

Takuro Saiki ◽

Masato Moriyama ◽

...

Keyword(s):

Risk Factors ◽

Lung Cancer ◽

Older Patients ◽

Performance Status ◽

Laboratory Data ◽

Age Groups ◽

Hematological Toxicity ◽

Male Sex ◽

Grade 3 ◽

A Performance

Introduction: Because of the increasing age of the general population, there is an increasing number of older patients with lung cancer. Cancer chemotherapy often causes severe hematological toxicity in older patients. Objective: This study aimed to explore the risk factors affecting the hematological toxicity of cytotoxic anticancer drugs in patients with lung cancer. Methods: Data were retrospectively collected from 194 patients with lung cancer at Niigata University Medical and Dental Hospital, Japan, between April 2011 and March 2016, when the patients underwent their first round of cytotoxic chemotherapy. The patients were divided into three groups on the basis of age: <65, 65–74, and ≥75 years. Physiological functions and laboratory data before treatment, as well as hematological adverse events following chemotherapy, were compared among the groups. Results: Patients aged ≥75 years were significantly more likely to experience grade 3 or 4 neutropenia, compared with patients aged <65 years. However, there were no differences in the incidence of anemia or thrombocytopenia among the age groups. The frequency of febrile neutropenia tended to increase with age. Multivariate analysis showed that age ≥75 years, male sex, and a performance status of ≥2 were independent factors for grade 3 or 4 neutropenia. Patients with 2 or 3 of these factors had a significantly higher frequency of neutropenia, compared with patients who had 0 or 1 of these factors. Conclusion: We found that age ≥75 years, male sex, and a performance status of ≥2 were independent risk factors for grade 3 or 4 neutropenia.

Download Full-text

Clinical Outcomes and Safety of Patients Treated with NAb-Paclitaxel Plus Gemcitabine in Metastatic Pancreatic Cancer: The NAPA Study

Current Cancer Drug Targets ◽

10.2174/1568009620999200918122426 ◽

2020 ◽

Vol 20 (11) ◽

pp. 887-895 ◽

Cited By ~ 1

Author(s):

Martina Catalano ◽

Giandomenico Roviello ◽

Raffaele Conca ◽

Alberto D’Angelo ◽

Valeria Emma Palmieri ◽

...

Keyword(s):

Performance Status ◽

Real Life ◽

Progression Free Survival ◽

Phase Iii ◽

Ductal Adenocarcinoma ◽

Hematological Toxicity ◽

Free Survival ◽

Grade 3 ◽

Ecog Ps ◽

Prognostic And Predictive Markers

Background: The phase III MPACT trial demonstrated the superiority of gemcitabine (Gem) combined with Nab-paclitaxel (Nab-P) versus gemcitabine alone in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (PDAC). The purpose of this study was to evaluate the effect of Gem/Nab-P in routine clinical practice. Methods: From January 2015 to December 2018, patients with metastatic PDAC receiving firstline treatment with a combination of gemcitabine and Nab-paclitaxel were included in a multicentre retrospective observational study. Exploratory analyses of efficacy, and prognostic and predictive markers, were performed. Results: The cohort comprised 115 patients (median age 65 [range 50-84] years) with good performance status (ECOG PS 0-1). The median overall survival (OS) was 11 months (95% CI; 9-13) and the median progression-free survival (PFS) was 6 months (95% CI 5-7). Partial response and stable disease were achieved in 44 and 30 patients, respectively, yielding an overall disease control rate (DCR) of 64.3%. Grade 3-4 hematological toxicity frequency was 22.61% for neutropenia, 5.22% for anemia, and 3.48% for thrombocytopenia. Grade 3 asthenia was recorded in 2.61% of patients. No grade 4 non-hematological events were reported. Dose reduction was necessary in 51.3% of the patients. Conclusions: Our results confirm the efficacy and safety of a first-line regimen comprising gemcitabine and Nab-paclitaxel in metastatic PDAC in a real-life population.

Download Full-text

Efficacy and safety of surgery for spontaneous pneumothorax in elderly patients

Interactive CardioVascular and Thoracic Surgery ◽

10.1093/icvts/ivz252 ◽

2019 ◽

Cited By ~ 1

Author(s):

Shunichi Nagata ◽

Mitsugu Omasa ◽

Kosuke Tokushige ◽

Takao Nakanishi ◽

Hideki Motoyama

Keyword(s):

Risk Factors ◽

Surgical Treatment ◽

Postoperative Complications ◽

Elderly Patients ◽

Spontaneous Pneumothorax ◽

Performance Status ◽

Multivariable Analysis ◽

Efficacy And Safety ◽

Air Leaks ◽

Grade 3

Abstract OBJECTIVES There is no clear consensus on the surgical indications for spontaneous pneumothorax in elderly patients. In this study, we aimed to assess the efficacy and safety of surgical treatment of spontaneous pneumothorax in patients aged ≥70 years. We also sought to identify the risk factors for postoperative prolonged air leaks and complications in such patients. METHODS Data pertaining to 104 elderly patients who underwent surgery out of 206 patients (aged ≥70 years) who were diagnosed with spontaneous pneumothorax at our institution between 1994 and 2018 were retrospectively reviewed. The incidences of postoperative persistent air leaks (≥2 days) and postoperative complications (≥grade 3; Clavien–Dindo classification) were analysed for efficacy and safety assessment, respectively. RESULTS Median postoperative air leaks continued for 0 days (range 0–25); 14.4% patients developed ≥grade 3 postoperative complications. On the basis of results of multivariable analysis, it was observed that a higher PaCO2 level was significantly associated with prolonged postoperative air leaks [odds ratio (OR) 1.08, 95% confidence interval (CI) 1.00–1.17; P = 0.047]. Poorer performance status was associated with a significantly increased risk of postoperative complications, as assessed by multivariable analysis (OR 6.13, 95% CI 1.38–27.3; P = 0.017). The recurrence rate was 4.8%; mortality rate of patients was 2.9%. Three-year survival rate after surgery was 73.8%. CONCLUSIONS Surgical treatment of spontaneous pneumothorax may be effective and safe in selected elderly patients. Moreover, higher PaCO2 and poorer performance status were independent risk factors for postoperative persistent air leaks and complications, respectively.

Download Full-text

Weekly Low Dose Epirubicin in Elderly Cancer Patients

Tumori Journal ◽

10.1177/030089169608200414 ◽

1996 ◽

Vol 82 (4) ◽

pp. 369-371 ◽

Cited By ~ 10

Author(s):

Dario Nicolella ◽

Giuseppe Grimaldi ◽

Giuseppe Colantuoni ◽

Mario Belli ◽

Giuseppe Frasci ◽

...

Keyword(s):

Side Effects ◽

Elderly Patients ◽

Cancer Patients ◽

Combination Chemotherapy ◽

Clinical Studies ◽

Low Dose ◽

Performance Status ◽

Elderly Cancer Patients ◽

Grade 3 ◽

Severe Mucositis

Aims and background The treatment of elderly patients with metastatic solid tumours is still a debated problem. Patients over 75 years are generally excluded from combination chemotherapy trials because of higher toxicity. Several clinical studies have shown that weekly low dose epirubicin is a well tolerated and effective treatment for elderly cancer patients (breast, prostate, lung). Methods We report a study of patients aged between 75 and 85 years affected by metastatic anthracyclines-sensible carcinomas, to assess the tolerance of epirubicin given weekly at a dose of 25 mg/m2. Results 25 patients (13 males, 12 females; ECOG P.S. 0-2) entered the study and were evaluable for side effects. One-hundred and ninety-six cycles of therapy have been administered. Side effects were never severe. Mucositis (9 patients), leucopenia (7 patients), anemia (5 patients) were usually of grade 1 or 2. Grade 1 cardiotoxicity (tachycardia) was observed in only one case. Grade 3 toxicity consisted in anemia (1 patient) and mucositis (1 patient), while grade 4 toxicity never occurred. Nineteen patients were evaluable for response: 0 CR, 4 PR (1 lung, 3 breast), 8 SD (3 lung, 3 breast, 2 prostate) have been observed. Compliance was encouraging and the majority of patients showed a decrease in symptoms and an improvement in performance status. Conclusions Weekly low-dose epirubicin is a very well tolerated treatment in elderly cancer patients. In view of the negligible toxicity encountered, it could be of utility to test this regimen in patients aged 75 years or older, affected by anthracyclines-sensible metastatic tumors, also to assess activity.

Download Full-text

Efficacy of combination-chemotherapy with pirarubicin, ifosfamide, and etoposide for soft tissue sarcoma: a single-institution retrospective analysis

BMC Cancer ◽

10.1186/s12885-020-07378-z ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Shiro Saito ◽

Hisaki Aiba ◽

Satoshi Yamada ◽

Hideki Okamoto ◽

Katsuhiro Hayashi ◽

...

Keyword(s):

Soft Tissue ◽

Soft Tissue Sarcoma ◽

Adverse Events ◽

Combination Chemotherapy ◽

Progressive Disease ◽

Treatment Phase ◽

Hematological Toxicity ◽

Single Institution ◽

Grade 3

Abstract Background The standard chemotherapy regimens for soft tissue sarcoma are doxorubicin-based. This retrospective study aimed to assess the efficacy and safety of pirarubicin, ifosfamide, and etoposide combination therapy for patients with this disease. Methods Between 2008 and 2017, 25 patients with soft tissue sarcoma were treated with pirarubicin (30 mg/m2, 2 days), ifosfamide (2 g/m2, 5 days), and etoposide (100 mg/m2, 3 days) every 3 weeks. The primary endpoint was overall response, and the secondary endpoint was adverse events of this regimen. Results Responses to this regimen according to RECIST criteria were partial response (n = 9, 36%), stable disease (n = 9, 36%) and progressive disease (n = 7, 28%). During the treatment phase, frequent grade 3 or worse adverse events were hematological toxicities including white blood cell decreases (96%), febrile neutropenia (68%), anemia (68%), and platelet count decreases (48%). No long-term adverse events were reported during the study period. Conclusion This regimen was comparable to previously published doxorubicin-based combination chemotherapy in terms of response rate. Although there were no long-lasting adverse events, based on our results, severe hematological toxicity should be considered.

Download Full-text

Beneficial Treatment Management with Trifluridine/Tipiracil in a Patient with Metastatic Colorectal Cancer and Pronounced Hematological Event History during Previous Treatments

Case Reports in Oncology ◽

10.1159/000486195 ◽

2018 ◽

Vol 11 (1) ◽

pp. 43-48 ◽

Cited By ~ 1

Author(s):

Volker Kaechele ◽

Jürgen Hess ◽

Wolfgang Schneider-Kappus

Keyword(s):

Colorectal Cancer ◽

Metastatic Colorectal Cancer ◽

Dose Reduction ◽

Performance Status ◽

Recommended Dose ◽

Hematological Toxicity ◽

Ecog Performance Status ◽

History Of ◽

Grade 3

Trifluridine/tipiracil (FTD/TPI) significantly improves overall survival in patients with metastatic colorectal cancer (mCRC). The most common treatment-related event (grade ≥3) was hematological toxicity. We here report long-term disease-stabilizing FTD/TPI treatment of an mCRC patient (KRAS wild-type, ECOG performance status 1 at baseline and at the end of FTD/TPI therapy) with multifocal synchronous metastases and a longstanding history of extensive hematological events during previous treatments. Finally, this 62-year-old male patient was treated for 10 months with FTD/TPI by consecutive alteration of treatment parameters: (i) initial daily dose reduction to 80 mg (72% of the recommended dose), (ii) 20 days dose delay, (iii) a second and later third dose reduction to 70 mg and 60 mg (about 64% and 55%, respectively, of the recommended dose), and (iv) 30 µg per day of granulocyte colony-stimulating factor administration first for 3 days, and later for 5 days, for each treatment cycle.

Download Full-text

A Score Model for Predicting Unsuccessful or Sub-Optimal Peripheral Blood Stem Cell Collections in Multiple Myeloma Based on a Retrospective Analysis of 1,039 Patients Receiving Novel Agents As Induction Therapy and Cyclophosphamide Plus G-CSF As Mobilizing Regimen,

Blood ◽

10.1182/blood.v118.21.4044.4044 ◽

2011 ◽

Vol 118 (21) ◽

pp. 4044-4044

Author(s):

Pellegrino Musto ◽

Alberto Grossi ◽

Ennio Sarli ◽

Michele Cavo ◽

Federica Leotta ◽

...

Keyword(s):

Risk Factors ◽

Multiple Myeloma ◽

Stem Cell ◽

Induction Therapy ◽

Peripheral Blood ◽

Novel Agents ◽

Predictive Score ◽

Hematological Toxicity ◽

Score Model ◽

Grade 3

Abstract Abstract 4044 Induction therapy with the so-called “novel agents” (bortezomib or IMIDs) followed by autologous stem cell transplantation (AuSCT) is considered the current standard therapeutic approach for younger patients with multiple myeloma (MM). However, a variable proportion of these patients still fails to mobilize and to collect a number of CD34+ peripheral blood stem cells (PBSC) sufficient for a safe transplant procedure or, as required in selected patients, for double or salvage AuSCTs. The aim of this study was to analyze, in a large number of MM initially treated with novel agents and homogeneously mobilized, the role of some potential risk factors on PBSC collection in patients eligible for AuSCT. To this purpose, the impact of age > 60 years, baseline cytopenia at diagnosis (Hb< 10 g/dl and/or neutrophil count < 1,000/μl and/or platelet count < 100,000/μl), initial use of lenalidomide and grade 3–4 hematological toxicity during induction therapy were retrospectively evaluated in 1,337 previously untreated MM patients enrolled in five consecutive clinical trials finalized to AuSCT and conducted by GIMEMA cooperative Group and MM Italian Network. In all cases, the mobilizing regimen was cyclophosphamide + G-CSF. In four of these studies, including 1,039 patients, induction regimens had comprised novel agents: thalidomide (TD, 296 patients), bortezomib (PAD, 121 patients), thalidomide plus bortezomib (VTD, 219 patients), lenalidomide (RD, 403 patients). 298 patients treated with a VAD-modified induction regimen (DAV) were also evaluated. Data were retrospectively extracted from two different databases of the coordinating Centers (Torino and Bologna) using a single, dedicated excel file. Total amounts of less than 2 and less than 5 × 10e6/kg CD34+ PBSC after a single mobilizing procedure were considered as “unsuccessful ” or “sub-optimal” results, respectively. Overall, 917 patients (68.6%) showed the presence of at least one risk factor: 615 patients (46%) had only 1 parameter, 302 a combination of 2 (n. 237, 17.7%), 3 (n. 56, 4.2%) or 4 (n. 9, 0.7%) parameters, respectively. After a single PBSC mobilization, 413 patients (30.9%) had a sub-optimal result, including 256 patients (19.1%) with unsuccessful collection. Any single parameter negatively influenced PBSC collection vs absence of parameters (p < 0.000). At multivariate analysis, however, grade 3–4 hematological toxicity (p < 0.000) and the use of lenalidomide (p < 0.013) during induction showed the most powerful negative effects on mobilization. The number of present risk factors (from 4 to 0) significantly paralleled the ineffective procedures, both in terms of absolute median amount of CD34+ PBSC collected (from 1.2 to 10.6 × 10e6/kg) or percentage of unsuccessful/sub-optimal collections (from 78% to 13% and from 89% to 24%, respectively) (p < 0.000). On these basis, we constructed a predictive score where the four parameters were pooled and weighted according to their relevance as single or combined variables, attributing the value of 3 for grade 3–4 hematological toxicity, 2 for the use of lenalidomide and 1 each for age > 60 and baseline cytopenia. Applying this model, we found that the risk of collecting less than 2 (27.5% vs 17.3%) and less than 5 (41% vs 28.6%) × 10e6/kg CD34+ PBSC, was significantly higher in patients with a total score equal or >3 than in patients scored <3 (p < 0.000 for both comparisons). These data did not differ significantly when the patients who had not received novel agents as induction therapy were excluded from the analysis. In conclusion, our score model provides a simple and effective method to predict unsatisfactory PBSC collections in MM patients eligible for AuSCT who have received novel agents as induction therapy and a combination of chemotherapy plus G-CSF as mobilizing treatment. Disclosures: Musto: Genzyme: Honoraria. Grossi:Genzyme: Consultancy. Sarli:Genzyme: Honoraria. Cavo:Genzyme: Honoraria. Boccadoro:Genzyme: Honoraria. Palumbo:Genzyme: Honoraria.

Download Full-text

A phase I clinical study of biweekly carboplatin and gemcitabine in patients with advanced solid tumors

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.12024 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 12024-12024

Author(s):

P. Kumar ◽

M. Keshtgarpour ◽

H. Kumar ◽

A. Dudek

Keyword(s):

Performance Status ◽

Median Number ◽

Maximum Tolerated Dose ◽

Hematological Toxicity ◽

Ecog Performance Status ◽

Primary Tumors ◽

Grade 3 ◽

Number Of Cycles ◽

Tumor Types ◽

Dose Levels

12024 Background: Carboplatin (CBDCA) and gemcitabine (GEM) in combination is used commonly in lung cancer and is administered on a 21 day cycle. The purpose of this study was to determine the maximum tolerated dose (MTD) of CBDCA and GEM administered on a biweekly schedule and to assess safety and efficacy of this schedule. Methods: GEM was given intravenously (IV) over 30 minutes followed by CBDCA also given IV over 30 minutes. This combination was given on day 1 every 2 weeks. The dose levels examined are shown in the Table . A total of 26 patients were studied (18 male, 8 female) with median age of 56 (range 41–83 years); ECOG performance status of 24 patients were 0 (5), 1 (16), 2 (2), 3 (1); prior chemotherapy ranged from 0 to 4 regimens; median number of cycles administered per patient was 3 (range 1–9) with a total of 81 cycles. The primary tumors were lung (11), melanoma (4), head and neck (3), squamous cell penile/toe (2), bladder (2), kidney (1), gastric (1), esophageal (1) and ovary (1). Results: No DLTs were seen in any of these patients and the MTD was not reached. Delay in treatment was seen in total of 6 cycles due to myelosuppression and 1 cycle due to nausea and anorexia. Grade 3/4 hematological toxicity rates: anemia - 3/81 cycles (3.7%), neutropenia - 20/81 cycles (25%), and thrombocytopenia - 4/81 cycles (5%). Non-hematological toxicity was mild. The median time to progression was 40 days (range 4–133) and of 18 evaluable patients partial response or stable disease was seen in 7 (38.8%). Conclusions: Even at maximum tested dose of GEM at 2000 mg/m2 and CBDCA at AUC of 3.0, this schedule is well tolerated. Hematological toxicity such as neutropenia and thrombocytopenia was minimal. We plan to study this schedule of GEM and CBDCA in appropriate tumor types in combination with biologic agents. [Table: see text] [Table: see text]

Download Full-text

A phase I study of S-1 administration and a 24-h infusion of cisplatin plus paclitaxel in patients with advanced gastric cancer

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.4074 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 4074-4074

Author(s):

H. Iwase ◽

M. Shimada ◽

T. Tsuzuki ◽

M. Okeya ◽

K. Kobayashi ◽

...

Keyword(s):

Gastric Cancer ◽

Antitumor Activity ◽

Advanced Gastric Cancer ◽

Dose Level ◽

Combination Chemotherapy ◽

Single Agent ◽

Fixed Dose ◽

Hematological Toxicity ◽

Level 3 ◽

Grade 3

4074 Background: S-1 may have a major role in the treatment of gastric cancer as single agent or as a component of combination chemotherapy in Japan. We previously reported a multicentric phase II study of S-1 combined with a 24-h infusion of cisplatin in patients with advanced gastric cancer. This combination was active, safe and had the possibility of being combined with other anticancer drug. Combination chemotherapy with S-1 and cisplatin plus paclitaxel for advanced gastric cancer might yield a stronger antitumor effect. The objective of this study was to determine the dose-limiting toxicity (DLT), the maximum tolerated dose (MTD), the recommended dose (RD), and the preliminary antitumor activity of S-1 and cisplatin plus paclitaxel for advanced gastric cancer. Methods: Paclitaxel was administered on day 1. A fixed dose of S-1 (70 mg/m2/day) was orally administered for 14 consecutive days from day 1, and a 24-h infusion of a fixed dose of cisplatin (60 mg/m2) was administered on day 14 of every 28-day cycle. Four dose escalation levels of paclitaxcel were studied (120, 140, 160, and 180 mg/m2). The DLT was defined as any of the following: grade 3 neutropenia lasting more than 5 days, grade 4 hematological toxicity, grade 3 non-hematological toxicity, or treatment delay of greater than 2 weeks as a result of toxicity. Results: Twenty patients were enrolled. Hematological and non- hematological toxicity of over grade 2 was not observed at dose level 1 and 2. Three patients started at dose level 3. One developed grade 3 neutropenia for 5 days following by grade 2 neutropenia lasted more than 10 days. Five more patients were added at this level. The treatment was delayed over 2 weeks in 1 out of 8 patients. Three patients started at dose level 4. One developed grade 3 neutropenia and needed longer than 14 days to recover. Three patients added this level. In total, at dose level 4 the treatment was delayed over 2 weeks in 3 out of 6 patients as a result of neutropenia. We considered level 4 is the MTD and the RD of paclitaxcel was 160 mg/m2 (dose level 3). The overall response rate was 75%. Conclusions: Triple combination chemotherapy consisting of S-1, cisplatin, and paclitaxel showed a tolerable dose of adverse reactions and favorable antitumor activity for gastric cancer. No significant financial relationships to disclose.

Download Full-text

Induction chemotherapy with S-1 plus cisplatin in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN)

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.15501 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 15501-15501

Author(s):

J. Chung ◽

Y. Choi ◽

H. Shin ◽

G. Choi ◽

W. Lee ◽

...

Keyword(s):

Performance Status ◽

Locally Advanced ◽

Local Treatment ◽

Complete Response ◽

Hematological Toxicity ◽

Common Grade ◽

Adequate Organ Function ◽

Grade 3 ◽

And Performance ◽

Mild Toxicity

15501 Background: This study was to assess the efficacy and safety profiles of the combination treatment with S-1 and Cisplatin in patients with locally advanced SCCHN. Methods: Eligible patients were defined as histologically confirmed SCCHN, stage III or IV with no evidence of distant metastasis, evaluable lesions, adequate organ function, age of 20–80 years, and performance status 0,1 or 2. Cisplatin was infused over 1 hour on day 1 (75 mg/m2) and S-1 was administered orally for 14 consecutive days (day 2–15). The dosages of S-1 were assigned according to the patients’ body surface area (BSA): 50 mg twice a day (BSA < 1.5m2), 60 mg twice a day (BSA > 1.5m2). Each course was repeated every 3 weeks. After 2 course, tumor response were evaluated by CT scan and laryngoscopy. If the patients achieved a response (complete response: CR, or partial response: PR), they received one more course of chemotherapy before undergoing the radiotherapy or operation as a definitive local treatment. Results: All 22 patients were assessable for response and toxicity. The overall response was 80.9% (CR: 3, PR: 14). The adverse reactions occurred 120 times in 54 courses of 22 cases. The most common grade 3/4 adverse events were neutropenia, which occurred in 8 patients. Non-hematological toxicity of grade 3 and 4 included nausea and vomiting in 4 patients, fever in one patient and, fatigue in one patient. Since the observation period is short, the analysis about survival rate is not obtained so far. Conclusions: S-1 plus Cisplatin combination chemotherapy is effective against locally advanced SCCHN with mild toxicity. No significant financial relationships to disclose.

Download Full-text