Improved complete response rate and survival in advanced head and neck cancer after three-course induction therapy with 120-hour 5-FU infusion and cisplatin

BACKGROUND Concurrent chemotherapy is a well-established treatment modality for locally advanced head and neck cancer. The concept of concurrent chemotherapy and radiation was introduced in an attempt to improve the local control and possibly influence the survival because of the high rate of local and distant failures observed with the combination of surgery and postoperative radiation. The relevance of this study was to assess the efficacy of our treatment and patience compliance and also study the effect in patients treated with cisplatin based concurrent chemo radiotherapy in advanced head and neck cancer. METHODS The prospective study was conducted in the Department of Radiotherapy, Government Medical college, Thrissur, Kerala comprising the newly diagnosed patients with locally advanced head & neck cancers over one year. Conventional radiotherapy with a dose of 66 Gy in 33 fractions over 6.5 weeks was given concurrently with Inj cisplatin 100 mg / 2 IV every 3 weeks and periodically followed up for one year. RESULTS This study revealed that complete response rate was higher in 61 – 70 year age group compared to lower age groups. Complete response cases were slightly higher in T1 disease compared to higher stages. Regarding nodal status, complete response and DFS were more in N0 tumours and worst in N3 tumours. It was found that complete response rates were slightly higher in stage III than stage IV. Comparing the grade of the tumour, complete response cases were slightly higher in WD and MD compared to PD. Complete response rate and disease free survival (DFS) were slightly higher in cases who had more than two chemotherapy cycles compared to one cycle. CONCLUSIONS Concurrent chemo radiation was not well tolerated in our study group. Only 23.5 % patients were able to complete the planned treatment. The positive side was that complete response was found in about 79.4 % of study patients & DFS at one year was 80 %. KEY WORDS Concurrent Chemo Radiation, Head and Neck Cancer, Cisplatin

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Influence of Delayed Tumor Clearance on Reliability of Complete Response Rate in Chemoradiotherapy for Head and Neck Cancer

Japanese Journal of Clinical Oncology ◽

10.1093/jjco/hym072 ◽

2007 ◽

Vol 37 (8) ◽

pp. 559-567

Author(s):

M. Kawashima ◽

H. Fujii ◽

R. Hayashi ◽

M. Tahara ◽

K. Nasu ◽

...

Keyword(s):

Head And Neck Cancer ◽

Head And Neck ◽

Neck Cancer ◽

Response Rate ◽

Complete Response Rate ◽

Complete Response ◽

Tumor Clearance

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Placebo-controlled randomized trial of infusional fluorouracil during standard radiotherapy in locally advanced head and neck cancer.

Journal of Clinical Oncology ◽

10.1200/jco.1994.12.12.2648 ◽

1994 ◽

Vol 12 (12) ◽

pp. 2648-2653 ◽

Cited By ~ 112

Author(s):

G P Browman ◽

C Cripps ◽

D I Hodson ◽

L Eapen ◽

J Sathya ◽

...

Keyword(s):

Head And Neck Cancer ◽

Head And Neck ◽

Neck Cancer ◽

Response Rate ◽

Complete Response Rate ◽

Performance Status ◽

Locally Advanced ◽

Eastern Cooperative Oncology Group ◽

Complete Response ◽

Survival Duration

PURPOSE To determine whether the addition of infusional fluorouracil (I-FU) to standard radiotherapy improves survival at acceptable toxicity in patients with locally advanced squamous cell head and neck cancer (SCHNC). PATIENTS AND METHODS Consenting patients with an Eastern Cooperative Oncology Group (ECOG) performance status < or = 2; with stage III or IV SCHNC of the oral cavity, oropharynx, hypopharynx, or larynx; and who were recommended for radiotherapy with curative intent received 66 Gy of radiation therapy delivered in 2-Gy fractions once daily 5 days per week for 6 1/2 weeks. Those in the experimental arm received I-FU 1.2 g/m2/d, as a 72-hour infusion in the first and third weeks of radiation. Saline infusions were used in the placebo arm. RESULTS One hundred seventy-five patients were randomized (88 to I-FU and 87 to placebo), and the treatment arms were well balanced. The complete response rate was 68% for I-FU and 56% for placebo (P = .04). The overall median survival duration was 33 months for I-FU and 25 months for placebo (P = .08). Progression-free survival also favored I-FU (P = .06). Toxicity was greater in I-FU patients, but did not interfere with the scheduled delivery or completion of radiation. CONCLUSION The addition of I-FU to standard radiation in SCHNC improved the complete response rate and was associated with beneficial trends in progression-free and overall survival compared with radiation alone. I-FU patients also experienced greater morbidity, but this did not compromise delivery of radiotherapy.

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The correlation of specific variables of tumor differentiation with response rate and survival in patients with advanced head and neck cancer treated with induction chemotherapy

Cancer ◽

10.1002/1097-0142(19890415)63:8<1487::aid-cncr2820630806>3.0.co;2-4 ◽

1989 ◽

Vol 63 (8) ◽

pp. 1487-1492 ◽

Cited By ~ 14

Author(s):

John F. Ensley ◽

Julie A. Kish ◽

Arthur A. Weaver ◽

John R. Jacobs ◽

Mohammad Hassan ◽

...

Keyword(s):

Head And Neck Cancer ◽

Head And Neck ◽

Induction Chemotherapy ◽

Neck Cancer ◽

Response Rate ◽

Advanced Head ◽

Tumor Differentiation

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Cisplatin and fluorouracil chemotherapy does not yield long-term benefit in locally advanced head and neck cancer: results from a single institution.

Journal of Clinical Oncology ◽

10.1200/jco.1991.9.8.1376 ◽

1991 ◽

Vol 9 (8) ◽

pp. 1376-1384 ◽

Cited By ~ 39

Author(s):

E E Vokes ◽

R Mick ◽

E P Lester ◽

W R Panje ◽

R R Weichselbaum

Keyword(s):

Head And Neck Cancer ◽

Adjuvant Chemotherapy ◽

Head And Neck ◽

Induction Chemotherapy ◽

Neck Cancer ◽

Survival Data ◽

Locally Advanced ◽

Local Therapy ◽

Complete Response ◽

Advanced Head

Fifty-one patients with locally advanced head and neck cancer were treated with three cycles of cisplatin at 100 mg/m2 followed by 5-day continuous infusion fluorouracil (5-FU) at 1,000 mg/m2/d as induction chemotherapy. Subsequent local therapy consisted of surgery for patients with resectable disease and/or radiotherapy. Three cycles of adjuvant chemotherapy were administered to patients with partial response (PR) or complete response (CR) to induction chemotherapy. Twenty-two patients (43%) had a clinical CR that was pathologically confirmed in 12 patients (24%), and 24 patients (47%) had a PR for an overall response rate of 90%. Local therapy included surgery in 24 patients (47%) and radiotherapy alone in 22 patients (43%). Adjuvant chemotherapy was administered to 32 patients (63%) frequently at great dose reduction. At a median follow-up of 90 months, the median survival is 22 months (95% confidence interval, 15 to 36 months), and the 5-year survival is 25%, with only five patients known to be alive and disease-free at this time. The median time to progression is 14 months, with 29 patients (57%) having documented progression of their head and neck cancer and eight (16%) having progression of a second neoplasm. Seven patients died of intervening medical events. This high incidence of second malignancies supports the continued investigation of chemoprevention for patients in CR. Despite the known high response rates achieved with cisplatin and 5-FU induction chemotherapy, the overall poor survival data reported here should lead to a thorough reexamination of the frequent administration of this regimen in the community.

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Cis-platinum and 5-fluorouracil as induction therapy for advanced head and neck cancer

The American Journal of Surgery ◽

10.1016/0002-9610(82)90419-6 ◽

1982 ◽

Vol 144 (4) ◽

pp. 445-448 ◽

Cited By ~ 70

Author(s):

Arthur Weaver ◽

Susan Flemming ◽

Julie Kish ◽

Henry Vandenberg ◽

John Jacob ◽

...

Keyword(s):

Head And Neck Cancer ◽

Head And Neck ◽

Neck Cancer ◽

Induction Therapy ◽

Advanced Head

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Concurrent chemoradiotherapy (crt) with weekly docetaxel (d) for advanced head and neck cancer

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.15516 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 15516-15516

Author(s):

G. López-Argumedo ◽

G. López-Vivanco ◽

R. Fernández ◽

I. Díaz de Corcuera ◽

A. Sancho ◽

...

Keyword(s):

Squamous Cell Carcinoma ◽

Head And Neck Cancer ◽

Cell Carcinoma ◽

Head And Neck ◽

Neck Cancer ◽

Squamous Cell ◽

Response Rate ◽

Stage Iii ◽

Advanced Head ◽

Percutaneous Gastrostomy

15516 Background: Concomitant CRT has become a standard treatment for advanced head and neck cancer. The aim of this study was to evaluate the efficacy and toxicity of concurrent CRT with D in patients (pts) with advanced squamous cell carcinoma of head and neck (SCCHN). Methods: Patients with untreated and unresectable stage III or IV (M0) squamous cell carcinoma of head and neck were included. Treatment consisted of D 20 mg/m2 weekly with concomitant radiotherapy 70 Gy (2 Gy per day, 7 weeks). Results: From September 03 to October 05, sixty-four pts with advanced SCCHN, were recruited. Gender: 61 male, 3 female. Mean age: 56.5 years old (range 42–77). ECOG PS 0/1/2: 0/57/7. Primary sites of disease: oral cavity 8, oropharynx 26, hypopharynx 15 and larynx 15. Stage III 16 pts and stage IV 48 pts. Compliance: 393 administrations of D were given, median 6, mean 6 (range 1–8). Fifty-five pts (86%) completed the radiotherapy dose planned (mean dose of RT was 66 Gy). One refused more treatment with D after first administration. Nineteen pts required supportive percutaneous gastrostomy or nasogastric tubes previously or during therapy. Grade 2/3/4 toxicity per patient: anemia 4/2/0, mucositis 21/24/0, dermatitis 21/20/0. Neither thrombopenia nor neutropenia were observed. Four pts died of aspiration pneumonia during treatment, one of gastric perforation and two of unknown causes. Fifty-six pts were evaluable for response: CR 28 (44%), PR 23 (36%), SD 2 (3%), PD 3 (5%), with an overall response rate of 80%. Median overall survival was 74.86 weeks (95% CI: 40.40–109.32) and median progression free survival was 48 weeks (95% CI: 18.80–77.20). With a median follow up of 40 weeks 34 pts (53%) were alive and 21 of them (33%) remained free of disease. Conclusions: Concurrent weekly D with conventional radiotherapy showed a high response rate. Toxicity was manageable and allowed maintaining radiotherapy administration. Taking into account poor prognostic factors of our series, survival results seem promising. No significant financial relationships to disclose.

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Phase I trial of chemotherapy combination with docetaxel, cisplatin and S-1 (TPS) in patients with locally advanced or recurrent/ metastatic head and neck cancer (HNC)

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.6064 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 6064-6064

Author(s):

M. Tahara ◽

K. Araki ◽

N. Kiyota ◽

S. Takeuchi ◽

N. Fuse ◽

...

Keyword(s):

Head And Neck Cancer ◽

Head And Neck ◽

Neck Cancer ◽

Response Rate ◽

Locally Advanced ◽

Complete Response ◽

Maximum Tolerated Dose ◽

Eligibility Criteria ◽

Adequate Organ Function ◽

Grade 3

6064 Background: An oral fluoropyrimidine, S-1, has shown high efficacy against head and neck cancer (HNC) with a response rate of 34% and preclinical data has demonstrated a possible synergy with platinums and taxanes. The aim of this study was to determine the maximum tolerated dose (MTD) of a combination therapy with TPS in patients (pts) with locally advanced or recurrent/ metastatic HNC. Methods: The eligibility criteria were: histologically proven squamous cell carcinoma of the head and neck with recurrent/metastatic and locally advanced lesions, PS 0–1, age =75 years, adequate organ function, and no prior chemotherapy. Chemotherapy consisted of 1-hour infusion of docetaxel at escalating doses of 50 and 60 mg/m2, 2-hour infusions of cisplatin at 70 mg/m2/day on day 1 and S-1 twice daily on days 1–14 at escalating doses of 40, 60, and 80 mg/m2/day. The treatment was repeated every 4-weeks. Results: Twenty two pts were enrolled. These were 17 males and 5 females with a median age of 50 years (22–74). There were 11 locally advanced and 11 metastatic cases. Median of 3 cycles were administrated (range 1–6; total 77 cycles). Anorexia, nausea, neutropenia and anemia were the most frequently observed adverse events. Grade 3 or 4 hematological toxicities were neutropenia (59%), febrile neutropenia (0%), anemia (14%) and thrombocytopenia (0%). Although a total of 12 pts were treated with TPS at doses of 60/70/80 mg/m2/day, one-dose limiting toxicity (grade3 infection) was observed at these doses, but MTD was not reached. As the approved dose of S-1 is 80 mg/m2, further dose escalation was not conducted. In a total of 22 pts treated with the TPS, 3 (1 locally advanced, 2 metastatic cases) achieved complete response and 11 (7 locally advanced, 4 metastatic cases) achieved partial response according to RECIST with an overall response rate of 64%. Conclusions: The TPS combination was well tolerated in pts with locally advanced or recurrent/ metastatic HNC. Although MTD was not reached and the data were preliminary, the antitumor activity was very promising, and this warrants further investigation. No significant financial relationships to disclose.

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